A Study of ARO-C3 in Healthy Adults and in Adults with Complement-Mediated Renal Disease
Research type
Research Study
Full title
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Disease
IRAS ID
1008693
Contact name
Kimberly Koop
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1/2a clinical study that includes a blinded, placebo-controlled study in healthy volunteers (Part 1) and an open-label study in patients with complement-mediated renal disease (Part 2). In Part 1, healthy volunteers will take 1 dose of ARO-C3 or placebo. Additional healthy volunteers will take a total of 2 doses of ARO-C3 (at a dose level studied previously) or placebo over time. After Part 1 is underway, Part 2 will begin. In Part 2, patients with complement-mediated renal disease (either C3G or IgAN) will take a total of 3 doses of ARO-C3 at specific times and at a dose level identified in Part 1. Before increasing the ARO-C3 dose level for participants in Part 1, a Data Safety Committee will evaluate all available safety data.
The study duration for each participant, from the beginning of the Screening period to the Day 169 end of study assessments, will be up to approximately 33 weeks. Participants may be asked to continue to return for evaluations beyond study Day 169 if the activity of certain proteins in their blood, such as serum CH50/AH50 complement activity (or equivalent measure of alternative pathway activity), have not returned to their original levels.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0308
Date of REC Opinion
9 Nov 2023
REC opinion
Further Information Favourable Opinion