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Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease

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ClinicalTrials.gov Identifier: NCT05083364
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : April 15, 2024
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief Summary:
The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy [C3G] and IgA Nephropathy [IgAN]). In Part 1 of the study, HVs will receive either one or two doses of ARO-C3 or placebo. In Part 2 of the study, adult patients with C3G/IgAN will receive 3 open-label doses of ARO-C3. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

Condition or disease Intervention/treatment Phase
C3 Glomerulopathy IgA Nephropathy Drug: ARO-C3 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1, participants are randomized to receive either ARO-C3 or placebo. Participants,care providers, investigator and outcomes assessors are all blinded to treatment assignment. Part 2 in patients with C3G or IgAN is open-label and there is no masking.
Primary Purpose: Treatment
Official Title: A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Disease
Actual Study Start Date : February 2, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-C3 (Healthy Volunteers)
1 or 2 doses of ARO-C3 by subcutaneous (sc) injection
 Drug: ARO-C3
ARO-C3 for sc injection
Placebo Comparator: Placebo (Healthy Volunteers)
placebo calculated volume to match active treatment by sc injection
 Drug: Placebo
sterile normal saline (0.9% NaCl) for sc injection
Experimental: ARO-C3 (Adult Patients with C3G or IgAN)
3 doses of ARO-C3 by sc injection
 Drug: ARO-C3
ARO-C3 for sc injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169 [ Time Frame: up to day 169 (End of Study [EOS]) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: up to 48 hours post-dose ]
  2. PK of ARO-C3: Area under the Plasma Concentration Versus Time Curve from Zero to 24Hours (AUC0-24) [ Time Frame: up to 48 hours post-dose ]
  3. PK of ARO-C3: Area Under the Plasma Versus Time Concentration Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast) [ Time Frame: up to 48 hours post-dose ]
  4. PK of ARO-C3: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf) PK of ARO-C3: [ Time Frame: up to 48 hours post-dose ]
  5. PK of ARO-C3: Terminal Elimination Half-Life (t1/2) [ Time Frame: up to 48 hours post-dose ]
  6. PK of ARO-C3: Apparent Total Body Clearance of ARO-C3 from Plasma (CL) [ Time Frame: up to 48 hours post-dose ]
  7. PK of ARO-C3: Volume of Distribution (Vz/F) [ Time Frame: up to 48 hours post-dose ]
  8. Pharmacodynamics (PD): Change From Baseline in Complement 3 (C3) up to Day 169 [ Time Frame: Baseline, through Day 169 (EOS) ]
  9. PD: Percent Change From Baseline in C3 up to Day 169 [ Time Frame: Baseline, through Day 169 (EOS) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (All Participants):

  • Willing to provide written informed consent and to comply with study requirements
  • Female participants must be non-pregnant/non-lactating
  • Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. C3G and IgAN participants must have been vaccinated or willing to undergo vaccination
  • All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae
  • Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
  • 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety at discretion of investigator
  • Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Males must not donate sperm during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later.
  • No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the investigator, could adversely impact participant safety or study results

Inclusion Criteria (C3G and IgAN Participants):

  • Diagnosis of C3G or IgAN
  • Clinical evidence of ongoing disease based on significant proteinuria
  • Estimated glomerular filtration rate ≥30 mL/Min/1.73 m2 at Screening and currently not on dialysis
  • Must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria (All Participants):

  • Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus
  • History of recurrent or chronic infections
  • Uncontrolled hypertension
  • Regular use of alcohol within 30 days prior to Screening
  • Use of illicit drugs within 1 year prior to Screening or positive urine drug screen at Screening
  • History of meningococcal infection
  • History of asplenia or splenectomy
  • Known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study
  • Any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Contacts and Locations
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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): NCT05083364


Contacts
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Contact: Clinical Operations Lead 626-304-3400 ARO-C3@arrowheadpharma.com

Locations
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Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05083364    
Other Study ID Numbers: AROC3-1001
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases