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COMPLETED
NCT05083364
PHASE1/PHASE2

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

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2022-02-01

Completion Date

2025-09-10

Last Updated

2026-05-22

Healthy Volunteers

Yes

Interventions

DRUG

ARO-C3

ARO-C3 for sc injection

DRUG

Placebo

sterile normal saline (0.9% NaCl) for sc injection

Locations (16)

Research Site 1

Camperdown, New South Wales, Australia

Research Site 3

Concord, New South Wales, Australia

Research Site 2

Clayton, Victoria, Australia

Research Site 2

Tbilisi, Georgia

Research Site 2

Cologne, Germany

Research Site 4

Erlangen, Germany

Research Site

Auckland, New Zealand

Research Site 1

Gamcheon, Busan, South Korea

Research Site 2

Haeundae, Busan, South Korea

Research Site 4

Goyang-si, Gyeonggi-do, South Korea

Research Site 3

Daegu, South Korea

Research Site 6

Soeul, South Korea

Research Site 8

Soeul, South Korea

Research Site 2

Bangkok, Thailand

Research Site 3

Chiang Mai, Thailand

Research Site 4

Oxford, United Kingdom