NCT05508204

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chinook Therapeutics, Inc. · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	BION-1301	A solution for SC injection administered as a single dose

Timeline

• Start date: 2022-07-19
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2022-08-19
• Last updated: 2023-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study