NCT07535775

Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers

A Phase Ib, Open-Label Study Investigating the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: SPH-BIOCAD (HK) Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	BCD-261	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection.

Timeline

• Start date: 2026-05-06
• Primary completion: 2026-10-10
• Completion: 2027-03-20
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China