A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
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.
∙ Phase Ia healthy participants must meet all of the following inclusion criteria to be enrolled:
• 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.
∙ Phase Ib participants with moderate to severe AD must meet all of the following inclusion criteria to be enrolled:
• 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 18-70 years (inclusive), any gender.
• Participant weight must be ≥ 45.0 kg.
• At screening, the diagnosis of AD meets the American Dermatology Consensus Criteria (2014) (see Appendix 4) and disease duration is ≥ 1 year; and at both screening and randomization, all of the following conditions are satisfied:
‣ EASI ≥ 16 at screening and baseline visits;
⁃ IGA ≥ 3 (on a 0 4 IGA scale, where 3 = moderate, 4 = severe) at screening and baseline visits;
⁃ Body surface area (BSA) of lesions ≥ 10% at screening and baseline visits.
• Prior to screening, the participant has received at least 4 weeks of potent or 2 weeks of super potent topical corticosteroids (or systemic corticosteroids), or topical calcineurin inhibitor.