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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

2026-07-08

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

BG-A3004

Administered subcutaneously

BIOLOGICAL

Placebo

Administered subcutaneously

Locations (5)

Beijing Tongren Hospital, Cmu

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, China