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RECRUITING
NCT07412691
PHASE1

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-03-19

Completion Date

2028-08-08

Last Updated

2026-03-23

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

BG-A3004

Administered subcutaneously

BIOLOGICAL

Placebo

Administered subcutaneously

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China