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
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.
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.
Sequential
BG-A3004
Biological/VaccineAdministered subcutaneously
Placebo
Biological/VaccineAdministered subcutaneously
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
Part A (SAD) and Part B (MAD): Maximum observed serum concentration of BG-3004 (Cmax)
Part A (SAD) and Part B (MAD): Area under the curve (AUC) of BG-3004
Part A (SAD) and Part B (MAD): Half-life of BG-3004 (t1/2)
Part A (SAD) and Part B (MAD): Number of Participants with Antidrug Antibodies (ADAs) against BG-A3004
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