NCT05083364

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• C3 Glomerulopathy
• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	ARO-C3	ARO-C3 for sc injection
DRUG	Placebo	sterile normal saline (0.9% NaCl) for sc injection

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-05-05
• Completion: 2025-10-31
• First posted: 2021-10-19
• Last updated: 2025-12-16

Locations

16 sites across 7 countries: Australia, Georgia, Germany, New Zealand, South Korea, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study