History of Changes for Study: NCT04809376

Version	Submitted Date	Changes
1	March 18, 2021	None (earliest Version on record)
2	January 30, 2022	Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Eligibility, Study Description, Oversight and Study Identification
3	March 31, 2022	Contacts/Locations and Study Status
4	April 4, 2024	Recruitment Status, Study Status, Contacts/Locations, Study Design, Study Description and Eligibility

Unique Protocol ID:

PARA_OA_002

Brief Title:

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium Versus Placebo in Participants With Knee Osteoarthritis Pain

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

Official Title:

A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain

Secondary IDs:

Record Verification:

March 2021

January 2022

Overall Status:

Not yet recruiting

Recruiting

Study Start:

June 26, 2021

October 19, 2021

Primary Completion:

August 17, 2022 [Anticipated]

October 15, 2023 [Anticipated]

Study Completion:

January 6, 2023 [Anticipated]

December 6, 2023 [Anticipated]

First Submitted:

March 18, 2021

First Submitted that
Met QC Criteria:

March 18, 2021

First Posted:

March 22, 2021 [Actual]

Last Update Submitted that
Met QC Criteria:

March 18, 2021

January 30, 2022

Last Update Posted:

March 22, 2021 [Actual]

February 14, 2022 [Actual]

Brief Summary:

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee osteoarthritis pain.

Study details include:

The study duration will be up to 28 weeks per participant
The treatment duration will be 6 weeks.
The visit frequency will be twice weekly during treatment..

Study details include:

The study duration will be up to 28 weeks per participant
The treatment duration will be 6 weeks.
The visit frequency will be twice weekly during treatment..

Detailed Description:

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain.

In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose regimens or placebo for 6 weeks. A minimum of 96 participants (24 within each dose group) will be assigned to the Pharmacokinetic (PK) subset.

Participants in Stage 1 will be randomly allocated to receive:

2 mg/kg calculated for ideal body weight (IBW) PPS twice weekly
2 mg/kg IBW PPS once weekly + placebo once weekly
100/150 mg PPS ≤65/>65 kg IBW once weekly + placebo once weekly
placebo twice weekly

In Stage 2, approximately 470 participants will be randomized 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. Approximately 150 participants (75 per group) will be assigned to the PK subset.

Participants in Stage 2 will be randomly allocated to receive:

One of the 3 Stage 1 PPS dose regimens selected by the DMC
placebo twice weekly

The maximum duration for each participant is approximately 28 weeks, which includes:

4-week Screening Period from Day -28 to Day -1
6-week Treatment Period from Day 1 to Day 39
18-week Follow-up Period from Day 40 to Day 168

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain.

Participants in Stage 1 will be randomly allocated to receive:

1.5 mg/kg calculated for ideal body weight (IBW) PPS twice weekly
2 mg/kg IBW PPS once weekly + placebo once weekly
100/150/180 mg PPS if ≤ 65 kg/ ≥ 65 kg and ≤ 90kg/ > 90kg IBW+ placebo once weekly
placebo twice weekly

Participants in Stage 2 will be randomly allocated to receive:

One of the 3 Stage 1 PPS dose regimens selected by the DMC
placebo twice weekly

The maximum duration for each participant is approximately 28 weeks, which includes:

4-week Screening Period from Day -28 to Day -1
6-week Treatment Period from Day 1 to Day 39
18-week Follow-up Period from Day 40 to Day 168

Arms

Assigned Interventions

Experimental: PPS Twice Weekly

Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks

Drug: Pentosan Polysulfate Sodium Sodium twice weekly

Subcutaneous Injection, 2 1.5mg/kg Ideal body Weight (IBW)

Other Names:

PPS twice weekly

Experimental: PPS Once Weekly

Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks

Drug: Pentosan Polysulfate Sodium

Subcutaneous Injection, 2mg/kg Ideal body Weight (IBW)

Drug: Placebo (Sodium Chloride Injection, 0.9%)

Placebo to match PPS

Other Names:

Placebo

Drug: Pentosan Polysulfate Sodium once weekly

Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW)

Other Names:

PPS once weekly

Experimental: PPS Fixed Dose Once Weekly

Pentosan Polysulfate Sodium (PPS) Fixed dose (100 mg or mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks

Drug: Placebo (Sodium Chloride Injection, 0.9%)

Placebo to match PPS

Other Names:

Placebo

Drug: Pentosan Polysulfate Sodium Fixed Dose

Subcutaneous Injection, 100/ 150 150/180 mg if ≤ <65 /> kg/ ≥ 65 kg and ≤ 90kg/ >90 kg IBW

Other Names:

Fixed Dose

Placebo Comparator: Placebo

Placebo twice weekly for 6 weeks

Drug: Placebo (Sodium Chloride Injection, 0.9%)

Placebo to match PPS

Other Names:

Placebo

Outcome Measures


Primary Outcome Measures:
1.	Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Day 56 ] WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.	Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Day 56 ] WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Secondary Outcome Measures:
1.		Key secondary: Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index [ Time Frame: Baseline to Day 56 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
2.		Key secondary: Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index [ Time Frame: Baseline to Day 84 ] WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
3.		Key secondary: Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index [ Time Frame: Baseline to Day 84 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
4.		Stage 1 only: Change from baseline at Day 56 and 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly [ Time Frame: Baseline to Day 56 and Day 84 ] WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
5.		Stage 1 only: Reduction in knee pain of ≥ 30% and ≥ 50% as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly [ Time Frame: Baseline to Day 56 and Day 84 ] WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
6.		Stage 1 only: Stage 1 only: Change from baseline at Day 56 and 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly [ Time Frame: Baseline to Day 56 and Day 84 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
7.		Stage 1 only: Improvement in function of ≥ 30% and ≥ 50% as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly [ Time Frame: Baseline to Day 56 and Day 84 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
8.		Stage 1 only: PGIC scores at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly [ Time Frame: Baseline to Day 56 and Day 84 ] The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
1 9.	Percentage of patients meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Days 39, 56, 84, 112, 140, and 168 [ Time Frame: Baseline, Days 39, 56, 84, 112, 140 and 168 ] Participants are considered as an OMERACT-OARSI responder: if the change (improvement) from baseline to day of interest was greater than or equal to >= 50 percent and >= 2 units in either WOMAC pain sub-scale or physical function sub-scale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain sub-scale score, 2) WOMAC physical function sub-scale score, 3) Patient Global Impression of Change (PGIC).	Stage 1 and 2: Outcomes Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index response rate at Days 39, 56, 84, 112, 140, and 168 [ Time Frame: Baseline, Days 39, 56, 84, 112, 140 and 168 ] Participants are considered as an OMERACT-OARSI responder: if the change (improvement) from baseline to day of interest was greater than or equal to >= 50 percent and >= 2 units in either WOMAC pain sub-scale or physical function sub-scale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain sub-scale score, 2) WOMAC physical function sub-scale score, 3) Patient Global Impression of Change (PGIC).
2 10.	Change from baseline at Days 11, 25, 39, 84, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 84, 112, 140 and 168 ] WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.	Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 112, 140 and 168 ] WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
3 11.	Change from baseline in knee pain of >=25% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140 and 168 ] Percentage of participants with reduction in WOMAC pain intensity of at least >=25% or >=50% compared to baseline as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.	Stage 1 and 2: Change from baseline in knee pain of >=30% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140 and 168 ] Percentage of participants with reduction in WOMAC pain intensity of at least >=30% or >=50% compared to baseline as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
4 12.	Change from baseline at Days 11, 25, 39. 56, 84, 112, 140 and 168 in function as assessed by the average functional sub-scale score of the WOMAC® Index. [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140 and 168 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.	Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in function as assessed by the average functional sub-scale score of the WOMAC® Index. [ Time Frame: Baseline, Days 11, 25, 39, 112, 140 and 168 ] WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
5 13.	Change from baseline in function of >=25% and >=50% as assessed by the average functional sub-scale score of the WOMAC® NRS 3.1 Index from baseline at Days 11, 25, 39, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140, and 168 ] Percentage of participants with improvement in WOMAC function of at least >=25% or >=50% compared to baseline as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.	Stage 1 and 2: Improvement in function of >=30% and >=50% as assessed by the average functional sub-scale score of the WOMAC® NRS 3.1 Index from baseline at Days 11, 25, 39, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140, and 168 ] Percentage of participants with improvement in WOMAC function of at least >=30% or >=50% compared to baseline as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
6 14.	Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in knee stiffness as assessed by the average stiffness sub-scale score of the WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] WOMAC: The WOMAC stiffness sub-scale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee) during the past 48 hours.	Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in knee stiffness as assessed by the average stiffness sub-scale score of the WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] WOMAC: The WOMAC stiffness sub-scale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee) during the past 48 hours.
7 15.	Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 overall as assessed by the overall score of WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] WOMAC: The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability.	Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 overall as assessed by the overall score of WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] WOMAC: The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability.
8 16.	Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week.	Stage 1 and 2: Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week.
9 17.	PGIC scores at Days 39, 56, 84 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ] The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".	Stage 1 and 2: PGIC scores at Days 39, 112, 140, and 168 [ Time Frame: Baseline, Days 39, 112, 140, and 168 ] The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
10 18.	Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score [ Time Frame: Baseline, Day 56, 84, 112, 140 and 168 ] This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons.	Stage 1 and 2: Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score [ Time Frame: Baseline, Day 56, 84, 112, 140 and 168 ] This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons.
11 19.	Number of days of rescue medication used from Day 1 to Day 168 [ Time Frame: Baseline up to Day 168 ] In case of inadequate pain relief, either acetaminophen/paracetamol up to 3000 mg per day or topical analgesics, up to 4 days in a week could be taken as rescue medication between day 1 and Day 168. Number of participants with any use of rescue medication during the particular study week will be summarized	Stage 1 and 2: Number of days of rescue medication used from Day 1 to Day 168 [ Time Frame: Baseline up to Day 168 ] In case of inadequate pain relief, either acetaminophen/paracetamol up to 3000 mg per day or topical analgesics, up to 4 days in a week could be taken as rescue medication between day 1 and Day 168. Number of participants with any use of rescue medication during the particular study week will be summarized
12 20.	Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs) upto end of study [ Time Frame: Baseline up to Day 168 ] An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in one or more of the following outcomes: death; life-threatening; requires in-patient hospitalization or prolongation of an existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; is an important medical event. Treatment-emergent are events between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state.	Stage 1 and 2: Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs) [ Time Frame: Baseline up to Day 168 ] An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in one or more of the following outcomes: death; life-threatening; requires in-patient hospitalization or prolongation of an existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; is an important medical event. Treatment-emergent are events between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state.
13 21.	Incidence of Treatment-emergent clinical laboratory abnormalities upto end of study [ Time Frame: Baseline up to Day 168 ] Treatment-emergent clinical laboratory abnormalities are abnormalities in labs between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state	Stage 1 and 2: Treatment-emergent clinical laboratory abnormalities [ Time Frame: Baseline up to Day 168 ] Treatment-emergent clinical laboratory abnormalities are abnormalities in labs between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state
14 22.	Incidence of clinically significant changes in electrocardiograms (ECG) compared with baseline at Day 15 and 39 [ Time Frame: Baseline, Day 1, Day 15 and Day 39 ] Clinically significant changes in ECGs between the first administration of study drug and up to Day 39 that were absent before treatment or that worsened relative to pre-treatment state.	Stage 1 and 2: Clinically significant changes in electrocardiograms (ECG) compared with baseline (pharmacokinetic [PK] subset only) [ Time Frame: Baseline, Day 1, Day 15, Day 36 and Day 39 ] Clinically significant changes in ECGs between the first administration of study drug and up to Day 39 that were absent before treatment or that worsened relative to pre-treatment state.
Other Outcome Measures:
1.	Number of participants with an Anti-Drug-Antibody (ADA) response at Days 11, 25, 39, 56 and 84 [ Time Frame: Baseline, Days 11, 25, 39, 56 and 84 ] Human serum ADA samples will be analyzed for the presence or absence of anti-drug-antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).	Exporatory: Number of participants with an Anti-Drug-Antibody (ADA) response after treatment [ Time Frame: Baseline, Days 11, 25, 39, 56 and 84 ] Human serum ADA samples will be analyzed for the presence or absence of anti-drug-antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
2.		Exploratory: Correlation of Anti-Drug-Antibody (ADA) response with clinical events [ Time Frame: Baseline, Days 11, 25, 39, 56, and 84 ] Human serum ADA samples will be analyzed for the presence or absence of anti-drug-antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
2 3.	Stage 1: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39 [ Time Frame: Stage 1: Day 1, 15 and 39 - pre-dose and 2, 4, and 6 hours. Pre-dose on Days 4, 8, 11, 18, 22, 25, 29, 32 and 36 ] Blood samples for assay of plasma PPS concentration will be obtained from a subset of patients before dosing and 2, 4, and 6 hours after dosing on study Days 1,15 and 39, and assayed using a sensitive, validated [binding, etc.] bioanalytical method. Plasma concentrations of PPS will be tabulated by time and participant and inspected for relationship to dose during titration and stable treatment phases.	Exploratory: PPS PK profile of single and multiple doses based on sparse blood sampling [ Time Frame: Stage 1: Day 1, 15 and 39 - pre-dose and 2, 4, and 6 hours. Pre-dose on Days 4, 8, 11, 18, 22, 25, 29, 32 and 36 ] Blood samples for assay of plasma PPS concentration will be obtained from a subset of patients before dosing and 2, 4, and 6 hours after dosing on study Days 1,15 and 39, and assayed using a sensitive, validated [binding, etc.] bioanalytical method. Plasma concentrations of PPS will be tabulated by time and participant and inspected for relationship to dose during titration and stable treatment phases.
4.		Exploratory: Change in subchondral BML area and volume on MRI from baseline at Day 168 [ Time Frame: screening, Day 168 ] Bone Marrow lesions (BML) will be evaluated for changes based on MRI imaging
5.		Exploratory: The effect of PPS on subchondral BML volume and area on MRI and whether these changes correlate with clinical outcomes [ Time Frame: screening, Day 168 ] Bone Marrow lesions (BML) will be evaluated for changes based on MRI imaging
6.		Exploratory: Changes in joint synovitis/effusion volume on MRI from baseline on Day 168 [ Time Frame: screening, Day 168 ] Synovitis/effusion will be evaluated for changes based on MRI imaging
7.		Exploratory: The effect of PPS on joint synovitis/effusion volume on MRI and whether these correlate with clinical outcomes [ Time Frame: screening, Day 168 ] Synovitis/effusion will be evaluated for changes based on MRI imaging
8.		Exploratory: Change in cartilage volume on MRI from baseline at Day 168 [ Time Frame: screening, Day 168 ] Cartilage volume will be evaluated for changes based on MRI imaging
9.		Exploratory: The effect of PPS on cartilage volume changes on MRI and whether these correlate with clinical outcomes [ Time Frame: screening, Day 168 ] Cartilage volume will be evaluated for changes based on MRI imaging
10.		Exploratory: Change in bone shape on MRI from baseline at Day 168 [ Time Frame: screening, Day 168 ] Bone shape will be evaluated for changes based on MRI imaging
11.		Exploratory: The effect of PPS on bone shape changes and whether these correlate with clinical outcomes [ Time Frame: screening, Day 168 ] Bone shape will be evaluated for changes based on MRI imaging
12.		Exploratory: Change in joint space width on MRI from baseline at Day 168 [ Time Frame: screening, Day 168 ] Joint space will be evaluated for changes based on MRI imaging
13.		Exploratory: The effect of PPS on joint space width changes and whether these correlate with clinical outcomes [ Time Frame: screening, Day 168 ] Joint space will be evaluated for changes based on MRI imaging
3 .	Stage 2: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39 [ Time Frame: Stage 2: Day 1, 15 and 39 - pre-dose and 2 and 4 hours. Pre-dose on Days 4, 8, 11, 18, 22, 25, 29, 32 and 36 ] Blood samples for assay of plasma PPS concentration will be obtained from a subset of patients before dosing and 2, 4, and 6 hours after dosing on study Days 1 15 and 39, and assayed using a sensitive, validated [binding, etc.] bioanalytical method. Plasma concentrations of PPS will be tabulated by time and participant and inspected for relationship to dose during titration and stable treatment phases.

Minimum Age:

18 Years

Maximum Age:

Sex:

All

Gender Based:

Accepts Healthy Volunteers:

Criteria:

Inclusion Criteria:

Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria.
Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
Osteoarthritis pain in the index knee unresponsive (ie, the participant still experiences pain) to conservative therapy for >=6 months preceding Screening, defined as history indicating that:
1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or participant is unable to take acetaminophen/paracetamol chronically/long term because of contraindication or inability to tolerate; AND
2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided sufficient pain relief or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening AND Day 1 AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing stairs at Screening AND Day 1.
Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening and Day 1.
Body mass index of >=18 to <=39.0 kg/m2
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Current non-pharmacologic treatment regimen for knee OA must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
Willing to stop treatment with oral and topical NSAIDs, opioids, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study.
Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.
Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements

Exclusion Criteria:

Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4]).
Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for >=3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
History of other disease that may involve the index joint, including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of osteoporosis and a minimally traumatic or atraumatic fracture).
History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
Current clinically significant medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's opinion, makes the participant unsuitable for the study. Chronic medical conditions will be allowed at the discretion of the Investigator but must be stable without necessitating medication changes within 30 days before Day 1.
Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin <=100 mg/day.
Previous treatment with PPS in any form.
Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory systemic therapy as follows:
1. Chronic use of corticosteroids: >=15 mg/day of oral prednisolone or equivalent daily,
2. Intermittent corticosteroids: >=40 mg/day of oral prednisolone or equivalent for 1 or more short courses of >3 days.
Use of bisphosphonates within 12 weeks before Day 1.
Use of denosumab and iloprost within 12 weeks before Day 1.
Use of a knee brace on the index knee within 2 weeks before Day 1.
Systemic steroids administered intravenously, intramuscularly, and orally for OA or other indications within 2 weeks before Day 1.
Intra-articular injections to the index knee: steroids within 12 weeks; hyaluronic acid or any other intra-articular injections within 24 weeks before Day 1.
Use of vitamins and dietary supplements known to alter haemostasis within 2 weeks before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric, vitamins C and E, vitamin K.
Participation in another clinical trial or administration of any IP or experimental product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >=2 × ULN at Screening.
Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection (detectable virus or diagnosis of AIDS); participants with HIV infection must be on chronic suppressive antiviral medication.
Radiographic evidence of any of the following conditions in any Screening radiograph: excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg, rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg, Paget's disease, metastatic calcifications), primary or metastatic tumour lesions, stress, or traumatic fracture.
Radiographic evidence of any of the following conditions at Screening:
1. subchondral insufficiency fractures
2. spontaneous osteonecrosis of the knee
3. osteonecrosis
4. pathologic fracture
Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the Investigator (at Screening).
Resting, supine blood pressure (BP) >=160 mmHg in systolic pressure or >=100 mmHg in diastolic pressure at Screening. If a participant is found to have uncontrolled and/or untreated significant hypertension at Screening and anti-hypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month before Screening.
Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting little or no self-care).
Major surgery or anticipated surgery during the study.
Currently hospitalized or any planned hospitalizations during the study.
Plan for total knee reconstruction in affected knee(s) during the study.
Knee surgery or trauma to the index knee within 1 year before Day 1.
A history of drug or alcohol abuse and/or dependence within the 12 months before Screening that, in the opinion of the investigator, may affect participant ability to comply with study requirements.
Contraindication to MRI scans.
An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.

Inclusion Criteria:

Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria 1986 criteria.
Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
Osteoarthritis pain in the index knee unresponsive (ie, the participant still experiences pain) to conservative therapy for ≥ 6 months preceding Screening, defined as history indicating that:
1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or participant is unable to take acetaminophen/paracetamol chronically/long term because of contraindication or inability to tolerate; AND
2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided sufficient pain relief or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening AND Day 1 AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing stairs at Screening AND Day 1.
Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening and Day 1.
Body mass index of >=18 to <=35.0 kg/m2
Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study.
Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.

Exclusion Criteria:

Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4]).
Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥ 3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
History of other disease that may involve the index joint, including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of osteoporosis and a minimally traumatic or atraumatic fracture).
History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies
Allergy or contraindication to Gadolinium contrast agents
Allergy or contraindication to Tetracosactide
Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1. Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, Cirrhosis (Child-Pugh stage B or C), uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery
Any cancer within the previous 5 years, except for basal cell carcinomas.
History of or current hyperkalemia and/or hyponatremia.
History or current autoimmune polyglandular syndromes
Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin ≤100 mg/day.
Previous treatment with PPS in any form.
Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory systemic therapy including all oral, inhaled, intranasal, intra-articular and topical corticosteroids (occasional limited use of over the counter hydrocortisone cream allowed; however, cannot be used within 1 week of any cortisol testing)
Use of opioids within 6 weeks before Day 1.
Use of bisphosphonates within 12 weeks before Day 1.
Use of denosumab and iloprost within 12 weeks before Day 1.
Use of a knee brace on the index knee within 2 weeks before Day 1.
Systemic steroids administered intravenously, intramuscularly, and orally for OA or other indications within 8 weeks before Day 1.
Intra-articular injections to the index knee: steroids within 24 weeks; hyaluronic acid or any other intra-articular injections within 24 weeks before Day 1.
Cannabinoids within 30 days before Day 1.
Use of vitamins and dietary supplements known to alter haemostasis within 2 weeks before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric, vitamins C and E, vitamin K.
Known prior exposure to heparin as determined by history of drug use or history of the following medical conditions or interventions: cardiac bypass surgery or thromboembolic disease
Treatment with dehydroepiandrosterone sulfates within 6 weeks before Day 1.
Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors within12 weeks before Day 1.
Biotin within 6 weeks before Day 1.
Megestrol Acetate within 6 weeks before Day 1
Any medication that alters sodium and/or potassium levels (see Table Prohibited Therapy)
Participation in another clinical trial or administration of any IP or experimental product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≥ 2 × ULN at Screening.
Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection (detectable virus or diagnosis of AIDS); participants with HIV infection must be on chronic suppressive antiviral medication.
Radiographic evidence of any of the following conditions in any Screening radiograph: excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg, rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg, Paget's disease, metastatic calcifications), primary or metastatic tumour lesions, stress, or traumatic fracture.
Radiographic evidence of any of the following conditions at Screening:
1. subchondral insufficiency fractures
2. spontaneous osteonecrosis of the knee
3. osteonecrosis
4. pathologic fracture
Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the Investigator (at Screening).
Resting, supine blood pressure (BP) ≥160 mmHg in systolic pressure or ≥100 mmHg in diastolic pressure at Screening. If a participant is found to have uncontrolled and/or untreated significant hypertension at Screening and anti-hypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month before Screening.
Evidence of pigmentary maculopathy identified by a retinal specialist during Screening.
Morning Cortisol ≤ 3 µg/dL.
Plasma renin concentration > ULN; ACTH <10 pg/ml; Morning Cortisol >3 µg/dL and <10 µg/dL and peak cortisol (by ACTH stimulation test) <18 µg/dL.
Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting little or no self-care).
Major surgery or anticipated surgery during the study.
Currently hospitalized or any planned hospitalizations during the study.
Plan for total knee reconstruction in affected knee(s) during the study.
Knee surgery or trauma to the index knee within 1 year before Day 1.
A history of drug or alcohol abuse and/or dependence within the 12 months before Screening that, in the opinion of the investigator, may affect participant ability to comply with study requirements.
Contraindication to MRI scans.
An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.

Central Contact Person:

Clinical Operations Director
Telephone: +61 492 922 860
Email: info@paradigmbiopharma.com

Study Officials:

Thomas Schnitzer
Principal Investigator
Northwestern University Feinberg School of Medicine

Locations:

United States, Alabama

Alabama Clinical Therapeutics, LLC
[Not yet recruiting]
Birmingham, Alabama, United States, 35209
Contact:Contact: Jill Andringa 205-833-2228 jill.andringa@actstudy.net
Contact:Principal Investigator: Srinivas Mallempati, MD

United States, California

Core Healthcare Group
[Not yet recruiting]
Cerritos, California, United States, 90703
Contact:Contact: Mayracezl Rodriguez 562-924-8880 mrodriguezchg@gmail.com
Contact:Principal Investigator: Francisco Badar, MD

United States, Illinois

Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Contact:Contact: Narina Simonian 312-503-5780 n-simonian@northwestern.edu

Northwestern University Feinberg School of Medicine
[Not yet recruiting]
Chicago, Illinois, United States, 60611
Contact:Contact: Katie Wilmsen 312-503-2315 katie.wilmsen@northwestern.edu
Contact:Principal Investigator: Thomas Schnitzer, MD

United States, Texas

Discovery Clinical Trials
[Not yet recruiting]
San Antonio, Texas, United States, 78258
Contact:Contact: Nicole Zarate Nzarate@discoverytrials.com
Contact:Principal Investigator: Brian MacGillivray, MD

Australia, New South Wales

Emeritus Research
[Recruiting]
Botany, New South Wales, Australia, 2019
Contact:Contact: Emily Blyth 0335096166 EmilyBlyth@emeritusresearch.com
Contact:Principal Investigator: Paul Bird, MD

Australian Clinical Research Network
[Recruiting]
Maroubra, New South Wales, Australia, 2035
Contact:Contact: Adrianna Mahfound 610283470645 adrianna@acrn.com.au
Contact:Principal Investigator: Mark Arya, MD

Australia, Queensland

Griffith University
[Not yet recruiting]
Southport, Queensland, Australia, 4222
Contact:Contact: Tracey Brumby 0481484286 t.brumby@griffith.edu.au
Contact:Principal Investigator: Randy Bindra, MD

Austrials Taringa
[Not yet recruiting]
Taringa, Queensland, Australia, 4068
Contact:Contact: Jennifer Smith 61 7 3278 5255 jenifer.smith@austrials.com.au
Contact:Principal Investigator: Ferdinandus de Looze, MD

Austrials Wellers Hill
[Not yet recruiting]
Tarragindi, Queensland, Australia, 4121
Contact:Contact: James Read 61 1300 190 841 James.read@austrials.com.au
Contact:Principal Investigator: Florence Tiong, MD

Australia, South Australia

Sportsmed
[Not yet recruiting]
Stepney, South Australia, Australia, 5069
Contact:Contact: Margie Kabbani 0281301207 margie.kabbani2@sportsmed.com.au
Contact:Principal Investigator: Mark Fisher, MD

Australia, Victoria

Emeritus Research
Camberwell, Victoria, Australia, 3124
Contact:Contact: Teresa Ringeri +61395096166 teresaringeri@emeritusresearch.com

Emeritus Research
[Recruiting]
Camberwell, Victoria, Australia, 3124
Contact:Contact: Teresa Ringeri +61395096166 teresaringeri@emeritusresearch.com
Contact:Principal Investigator: Andrew Ostor, MD

Australia, Western Australia

Linear Clinical Research Limited
[Not yet recruiting]
Nedlands, Western Australia, Australia, 6009
Contact:Contact: Behin Sundar Raj braj@linear.org.au
Contact:Principal Investigator: Charles Inderjeeth, MD