This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.
The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.
Age at the time of signing the informed consent form is 18-55 years (inclusive), any gender.
Male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg; body mass index [BMI] is 18.0-28.0 kg/m² (inclusive).
No clinically significant abnormalities.
History of any clinically significant disease of the cardiovascular, hematological, hepatic, renal, digestive, neurological, respiratory, or psychiatric systems, or metabolic disorders, or any other disease or physiological condition that may interfere with the trial results.
History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis.
Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are unsuitable for subcutaneous injection.
Clinical signs of active infection within 4 weeks prior to randomization, including but not limited to urogenital infection, pulmonary infection, acute sinusitis, appendicitis, bloodstream infection, etc.
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Treatment groupsSee each treatment group below.