Skin Diseases
Conditions
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
Interventions
BIOLOGICALBG-A3004
Administered subcutaneously
BIOLOGICALPlacebo
Administered subcutaneously
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A (SAD) and Part B (MAD): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 24 weeks for Part A and 36 weeks for Part B | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicine
Outcome results
None listed