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Study of ARO-CFB in Adult Healthy Volunteers and Patients With Complement-Mediated Kidney Disease

IgA Nephropathy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06209177
Study type Interventional
Source Arrowhead Pharmaceuticals
Contact Medical Monitor
Phone 626-696-4702
Email gshekhtman@arrowheadpharma.com
Status Recruiting
Phase Phase 1
Start date April 22, 2024
Completion date March 2027
View Details
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