RecruitingPhase 1NCT07412691

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


Sponsor

BeOne Medicines

Enrollment

98 participants

Start Date

Mar 19, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BG-A3004 and a biological treatment called Placebo for people with skin diseases. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBG-A3004

Administered subcutaneously

BIOLOGICALPlacebo

Administered subcutaneously


Locations(11)

Beijing Tongren Hospital, Cmu

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07412691


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