Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
Led by BeOne Medicines · Updated on 2026-03-23
98
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human study to evaluate BG-A3004, a biological treatment being studied for safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics. The trial includes healthy participants and patients with immune-mediated skin diseases such as alopecia areata, cutaneous lichen planus, and nonsegmental vitiligo. This phase 1, randomized, double-blind, placebo-controlled study aims to better understand how BG-A3004 behaves in the body and its effects in these groups over about three years. The study has two parts: Part A involves healthy participants receiving a single subcutaneous dose of BG-A3004 or placebo, with sequential dose escalation. Part B includes patients with immune-mediated skin diseases receiving multiple subcutaneous doses of BG-A3004 or placebo across increasing dose levels. Part A participants get one dose, while Part B participants receive four doses. Safety follow-up continues for 168 days after the last dose in both parts. Participants will undergo medical evaluations, laboratory tests, and cardiac monitoring before and during the study. Researchers will monitor adverse events and serious adverse events for up to 24 weeks in Part A and 36 weeks in Part B. They will also measure drug concentration, half-life, and antibody formation against BG-A3004. The total study duration is approximately three years, including dosing, safety follow-up, and assessments to understand how the drug interacts with the body and its safety profile.
CONDITIONS
Brief Title
A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent indicating understanding of the study
- Female participants of childbearing potential must use highly effective birth control and have a negative pregnancy test before first dose
- Nonsterile male participants must use highly effective birth control and avoid sperm donation during the study and for 180 days after last dose
- Part A: Healthy participants aged 18 to 55 years with BMI 19 to 28 kg/m²
- Part B: Patients aged 18 to 60 years with BMI 18 to 32 kg/m²
- Part B: Patients with alopecia areata with SALT score between 25 and 95
- Part B: Patients with cutaneous lichen planus with IGA score of 3 or 4
- Part B: Patients with nonsegmental vitiligo for at least 3 months with F-VASI ≥ 0.5 and Total body-VASI ≥ 3
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to the study drug or similar drugs
- Unable to comply with study protocol without medical monitor approval
- History of malignancy within 5 years except locally treated cancer
- Received live vaccine within 28 days before randomization
- Pregnant or breastfeeding females
- History of tuberculosis or active/latent infection
- Known primary immunodeficiency or conditions predisposing to infection such as HIV or splenectomy
- Infection with hepatitis B or hepatitis C viruses
- History or signs of lymphoproliferative disorders, lymphoma, leukemia, or related diseases
- Active infection or infection requiring hospitalization or antimicrobial therapy within 6 months before dosing
- Symptomatic herpes zoster or herpes simplex within 12 weeks or recurrent episodes
- Acute illness like asthma attack, nausea, vomiting, fever, or diarrhea within 7 days prior to dosing
- Part B: Previous use of any Janus Kinase (JAK) inhibitor
- Part B: Use of systemic immunomodulatory medications within 4 weeks or 5 half-lives before randomization
- Part B: Phototherapy or cryotherapy within 4 weeks before randomization
- Part B: For alopecia areata patients, involvement beyond scalp hair
- Part B: For cutaneous lichen planus patients, predominantly bullous variant
- Part B: For nonsegmental vitiligo patients, no pigmented hair within facial vitiligo areas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks for single ascending doses and up to 36 weeks for multiple ascending doses
Participants receive either single or multiple subcutaneous doses of BG-A3004 or placebo depending on the study part and cohort assignment.
Visits scheduled according to dosing and safety monitoring throughout treatment period
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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