drugset / Trial / NCT07412691

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

NCT07412691 ↗

Phase 1 Recruiting 98 enrolled BeOne Medicines
RandomizedSequentialDouble-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject BG-A3004 Unknown — Subcutaneous

Indications