This is a Phase I/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).
The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients).
The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.
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 55 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 18.0 and 28.0 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.
Known or suspected allergy or intolerance to any component or excipient of HXN6005 injection or placebo.
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.
Parallel
HXN6005
DrugParticipants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Placebo
DrugParticipants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
HXN6005
DrugParticipants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Placebo
DrugParticipants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
HXN6005
DrugParticipants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Placebo
DrugParticipants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
6
Treatment groupsSee each treatment group below.
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)
Part C Efficacy
Change from baseline to Week 16 in the Eczema Area and Severity Index (EASI; range 0-72; higher scores indicate more severe disease) total score among AD participants
Maximum Observed Plasma Concentration (Cmax)
The maximum (peak) observed drug concentration in plasma after administration
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration
Incidence of antidrug antibodies (ADA) against HXN6005
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
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