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

NCT07412691 | Recruiting Phase 1

• 1 other identifier: BG-A3004-101
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Part A (SAD) and Part B (MAD): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant abnormalities from laboratory tests, vital signs and electrocardiogram results

  up to 24 weeks for Part A and 36 weeks for Part B

Secondary Outcomes (5)

• Part A (SAD) and Part B (MAD): Maximum observed serum concentration of BG-3004 (Cmax)

  up to 24 weeks for Part A and 36 weeks for Part B

• Part A (SAD) and Part B (MAD): Area under the curve (AUC) of BG-3004

  up to 24 weeks for Part A and 36 weeks for Part B

• Part A (SAD) and Part B (MAD): Half-life of BG-3004 (t1/2)

  up to 24 weeks for Part A and 36 weeks for Part B

• Part A (SAD) and Part B (MAD): Number of Participants with Antidrug Antibodies (ADAs) against BG-A3004

  up to 24 weeks for Part A and 36 weeks for Part B

• Part B (MAD): Trough concentration (Ctrough) of BG-3004

  up to 36 weeks

Study Arms (4)

Part A: Single Ascending Doses (SAD) of BG-A3004

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-A3004 will be evaluated after a single dose in healthy participants.

Biological: BG-A3004

Part B: Multiple Ascending Doses (MAD) of BG-A3004

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-A3004 will be evaluated after multiple doses in participants with immune-mediated skin diseases.

Biological: BG-A3004

SAD Placebo

PLACEBO COMPARATOR

Sequential cohorts of healthy participants will receive a single dose of matching placebo.

Biological: Placebo

MAD Placebo

PLACEBO COMPARATOR

Sequential cohorts of participants with immune-mediated skin diseases will receive multiple doses of matching placebo.

Biological: Placebo

Interventions

BG-A3004 BIOLOGICAL

Administered subcutaneously

Part A: Single Ascending Doses (SAD) of BG-A3004; Part B: Multiple Ascending Doses (MAD) of BG-A3004

Placebo BIOLOGICAL

Administered subcutaneously

MAD Placebo; SAD Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
• Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 180 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.
• Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 180 days after the last dose of study drug.
• Healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
• must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
• Body mass index (BMI) of 19 to 28 kg/m\^2
• Must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
• Body mass index (BMI) of 18 to 32 kg/m\^2
• Patients with alopecia areata (AA), clinical diagnosis of AA with no other etiology of hair loss. Severity of Alopecia Tool (SALT) ≥ 25 and \< 95 at screening and randomization.
• Patients with cutaneous lichen planus (CLP), clinical and histological features of LP with predominant cutaneous involvement. Investigator's Global Assessment (IGA) score of 3 or 4 at screening and randomization.
• Patients with nonsegmental vitiligo (NSV), documented clinical diagnosis of NSV for at least 3 months. Facial-Vitiligo Area Scoring Index (F-VASI) ≥ 0.5 and Total body-VASI ≥ 3 at screening and randomization.

You may not qualify if:

• Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of the study drug or drugs of the same class.
• Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
• Participants with any malignancy ≤ 5 years before randomization, except for any locally recurring cancer that has been treated curatively
• Participants who were administered a live vaccine ≤ 28 days before randomization.
• Female participants who are pregnant or are breastfeeding.
• History of Tuberculosis or active, latent, or inadequately treated infection
• A known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predispose the participant to infections.
• Known infection with hepatitis B virus \[presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody( HBcAb)\], or presence of hepatitis C virus antibody (HCV Ab)
• Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus-related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
• Have an active infection or a history of infection within 6 months before the first dose of study drug that required hospitalization, or parenteral antimicrobial therapy, or have a history of opportunistic infection or a chronic or recurrent infectious disease that, in the opinion of the investigator, makes them unsuitable for this study.
• Have or have had symptomatic herpes zoster or herpes simplex within 12 weeks, more than 1 episode of local herpes zoster, or a history (single episode) of disseminated zoster.
• Acute disease state (e.g., asthma attack, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.
• Previous use of any Janus Kinase (JAK) inhibitor for any disease indication at any time.
• Treatment with systemic immunomodulatory medications within 4 weeks or 5 half-lives (if known), whichever is longer prior to randomization, including immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine); corticosteroids administered orally, intravenously, or intramuscularly; chloroquine derivatives; and oral phosphodiesterase-4 (PDE4) inhibitors (e.g., apremilast).
• Phototherapy (UV or laser therapy) or cryotherapy within 4 weeks prior to randomization.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Study Director

  BeOne Medicine

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

+1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): August 8, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (1)