New skin disease drug enters first human trials
NCT ID NCT07412691
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 6 times
Summary
This study tests a new drug called BG-A3004 for the first time in humans. It aims to check the drug's safety and how the body processes it in healthy volunteers and people with immune-related skin diseases. The study is split into two parts: single dose in healthy people and multiple doses in patients. Results will help decide if further testing is warranted.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * 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. Part A (SAD) specific Inclusion criteria * 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 Part B (MAD) specific inclusion criteria: * 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. Exclusion Criteria: * 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. Part B(MAD) specific exclusion criteria: * 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. * For AA patients, AA that affects more than scalp hair, e.g., eyebrow, eyelash, body hair. * For CLP patients, Patients whose LP is a predominantly bullous variant. * For NSV patients, Participants who have no pigmented hair within any of the vitiligo areas on the face. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Beijing Tongren Hospital, Cmu
RECRUITINGBeijing, Beijing Municipality, 100010, China
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Hangzhou First Peoples Hospital
RECRUITINGHangzhou, Zhejiang, 310006, China
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Huashan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100034, China
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Suzhou Municipal Hospital
RECRUITINGSuzhou, Jiangsu, 215002, China
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The First Affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, 630014, China
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The First Affiliated Hospital of Fujian Medical University
RECRUITINGFuzhou, Fujian, 350005, China
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The First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325000, China
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The First Hospital of China Medical University
RECRUITINGShenyang, Liaoning, 110001, China
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The Second Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050000, China
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Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410008, China
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