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Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:
BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects

Clinical Trial Summary

Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.

Clinical Trial Description

This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3 dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05508204
Study type Interventional
Source Chinook Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 19, 2022
Completion date December 16, 2022
View Details
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