Study of ARO-CFB in Adult Healthy Volunteers and Patients With Complement-Mediated Kidney Disease
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs) and in adult patients with complement-mediated kidney disease (IgA Nephropathy \[IgAN\]). In Part 1 of the study, HVs will receive either one or two doses of ARO-CFB or placebo. In Part 2 of the study, adult patients with IgAN will receive 3 open-label doses of ARO-CFB. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.