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

IgA Nephropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05083364
Study type Interventional
Source Arrowhead Pharmaceuticals
Contact Clinical Operations Lead
Phone 626-304-3400
Email ARO-C3@arrowheadpharma.com
Status Recruiting
Phase Phase 1
Start date February 2, 2022
Completion date June 2025
View Details
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