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Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease
Sponsor: Arrowhead Pharmaceuticals
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
Conditions
Interventions
ARO-C3
ARO-C3 for sc injection
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