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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
Administered subcutaneously
Administered subcutaneously
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSuzhou Municipal Hospital
Suzhou, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGHuashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGHangzhou First Peoples Hospital
Hangzhou, Zhejiang, China
RECRUITING...and 1 more locations
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
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Part A (SAD) and Part B (MAD): Maximum observed serum concentration of BG-3004 (Cmax)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Part B (MAD): Trough concentration (Ctrough) of BG-3004
Time frame: up to 36 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.