The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    BION-1301
Previous Study | Return to List | Next Study

Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05508204
Recruitment Status : Completed
First Posted : August 19, 2022
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Chinook Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: BION-1301 Phase 1

Detailed Description:
This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3 dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level cohorts.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single ascending dose study in Japanese healthy subjects
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects
Actual Study Start Date : July 19, 2022
Actual Primary Completion Date : December 16, 2022
Actual Study Completion Date : December 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort A
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A
 Drug: BION-1301
A solution for SC injection administered as a single dose
Experimental: Cohort B
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B
 Drug: BION-1301
A solution for SC injection administered as a single dose
Experimental: Cohort C
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C
 Drug: BION-1301
A solution for SC injection administered as a single dose


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability of BION-1301 [ Time Frame: Day 85 ]
    Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); changes from baseline in safety parameters; and number of subjects with injection site reactions


Secondary Outcome Measures :
  1. Pharmacokinetics-Cmax [ Time Frame: Day 85 ]
    Maximum plasma concentration

  2. Pharmacokinetics-Tmax [ Time Frame: Day 85 ]
    Time at which the maximum plasma concentration (Cmax) occurs

  3. Pharmacokinetics-AUC∞ [ Time Frame: Day 85 ]
    Area under the plasma concentration-time curve from dosing (time zero) extrapolated to infinity

  4. Pharmacokinetics-AUClast [ Time Frame: Day 85 ]
    Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration

  5. Pharmacokinetics-t1/2 [ Time Frame: Day 85 ]
    Time required for the drug concentration to decrease by a factor of one-half in the terminal phase

  6. Pharmacokinetics-CL/F [ Time Frame: Day 85 ]
    Serum concentration after single dose will be measured and the apparent oral clearance will be calculated

  7. Pharmacokinetics-Vz/F [ Time Frame: Day 85 ]
    Serum concentration after single dose will be measured and the apparent volume of distribution will be calculated

  8. The effect of BION-1301 on pharmacodynamic (PD) parameters [ Time Frame: Day 85 ]
    Changes in immunoglobulin levels (IgA, IgG, and IgM)

  9. The levels of anti-drug antibodies [ Time Frame: Day 85 ]
    Blood anti-drug antibodies (ADA) and neutralizing antibody (NAb) levels


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First generation Japanese (confirmed at screening). The definition of first generation is the subject, the subject's biological parents, and the subject's biological grandparents are of exclusively Japanese origin and were born in Japan.
  • Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, at screening with a weight of at least 47 kg.
  • In good health, as determined by medical history, physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations within normal reference ranges or outside of normal reference ranges considered not clinically relevant by the investigator
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test, must agree to try to not become pregnant, must agree to consistently use highly effective contraceptive methods, and must agree not to breastfeed or donate ova for a period as defined in the study protocol.
  • Male subjects must agree to use highly effective contraceptive methods and must not donate sperm for a period as defined in the study protocol.

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
  • History of malignancy during the last 3 years; exceptions include adequately treated basal cell carcinoma and squamous cell carcinoma of the skin
  • Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute at either screening or predose on Day 1.
  • Received a live (attenuated) vaccine(s) within 3 months prior to check-in and/or a vaccine(s) that do not contain live microorganism(s) within 14 days prior to check-in.
  • Have previously completed or withdrawn from this study or any other study investigating BION-1301, and have previously received BION-1301.
  • Positive urine drug screen, alcohol test, or cotinine test at screening or check-in.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05508204


Locations
Layout table for location information
United States, California
Collaborative Neuroscience Research, LLC
Long Beach, California, United States, 90806
Sponsors and Collaborators
Chinook Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Charlotte Jones-Burton, M.D. Chinook Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chinook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05508204    
Other Study ID Numbers: CHK02-01
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No