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Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

IgA Nephropathy Clinical Trial

Official title:
A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

Clinical Trial Summary

Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).

Clinical Trial Description

This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. The study will be conducted in three parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period Parts 1 and 2 have been completed. Part 3 enrollment is complete. Part 4 enrollment is open for eligible participants from Part 3. The study will enroll up to 40 participants with IgAN. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03945318
Study type Interventional
Source Chinook Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date April 8, 2019
Completion date October 2026
View Details
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