This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN5003 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD). The study consists of two parts: Part A (single ascending dose in healthy participants) and Part B (multiple ascending dose in AD patients). The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of HXN5003.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.
AD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.
AD Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Part A Adverse events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Time frame: Up to day 197
Part B Adverse Events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Time frame: Up to day 281
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