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

NCT07412691 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-03-23

No results posted yet for this study

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

BIOLOGICAL

BG-A3004

Administered subcutaneously

BIOLOGICAL

Placebo

Administered subcutaneously

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2028-08-08
Completion
2028-08-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412691 on ClinicalTrials.gov