NCT07412691

A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases

A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in different dose levels in healthy participants (Part A) and patients with immune-mediated skin diseases (Part B), respectively. Study details include: * The study duration will be approximately 3 years. * The treatment duration will be 1 dose for Part A and 4 doses for Part B. * Safety follow-up period is 168 days after the last dose

Conditions

• Skin Diseases

Interventions

Type	Name	Description
BIOLOGICAL	BG-A3004	Administered subcutaneously
BIOLOGICAL	Placebo	Administered subcutaneously

Timeline

• Start date: 2026-03-19
• Primary completion: 2028-08-08
• Completion: 2028-08-08
• First posted: 2026-02-17
• Last updated: 2026-03-23

Locations

1 site across 1 country: China