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.
Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
(Healthy Participants) Male or female participants aged 18 to 50 years (inclusive) at the time of signing the ICF.
(Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
(Patients with AD) Male or female participants aged 18 to 70 years (inclusive)
Presence of any clinically significant disease at randomization, as judged by the investigator.
History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection.
Participants who have resided long-term in regions with high prevalence of Human Herpesvirus-8 (HHV-8), such as Africa or the Mediterranean coastal areas.
Parallel
HXN5003
DrugHealthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.
Placebo
DrugHealthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.
HXN5003
DrugAD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.
Placebo
DrugAD Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Part A Adverse events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Part B Adverse Events
Incidence, severity, and causal relationship of Adverse Events (AEs)
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