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A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ARO-CFB in Adult Healthy Volunteers and Adult Patients With Complement-Mediated Kidney Disease
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
Details
| Lead sponsor | Arrowhead Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 49 |
| Start date | 2024-04-05 |
| Completion | 2026-03 |
Conditions
- IgA Nephropathy
Interventions
- ARO-CFB
- Placebo
Primary outcomes
- Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) — up to Day 169 (End of Study [EOS])
Countries
New Zealand