HSK-44459

Phase I
Study Objectives:
* Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis.
* Secondary: Evaluate the pharmacokinetic (PK) profile of HSK44459 cream in the same populations (healthy adults and plaque psoriasis patients).
Participant Allocation:
- 10 healthy adults and 10 plaque psoriasis patients are enrolled. Participants are randomized to either the HSK44459 cream group (8 per population) or the vehicle (placebo - like) control group (2 per population).
Treatment Schedule:
* Day 1: Single - dose administration (one application).
* Days 2-3: Washout period (no medication).
* Days 4-9: Twice - daily administration.
* Day 10: One application.
Phase II
Study Objectives:
* Primary: Conduct a preliminary evaluation of the efficacy of HSK44459 cream in treating plaque psoriasis.
* Secondary: Assess the safety and tolerability of HSK44459 cream in plaque psoriasis patients.
Evaluate the PK profile of HSK44459 cream in plaque psoriasis patients.
Participant Allocation:
- 160 plaque psoriasis patients are enrolled and randomized in a 1:1:1:1 ratio to four groups: 1% HSK44459 cream (40 patients), 0.3% HSK44459 cream (40 patients), 0.1% HSK44459 cream (40 patients), or vehicle control (40 patients).
Treatment Schedule:
Phase II: The study consists of three phases (screening, treatment, and follow - up)
* Screening Period (D - 28 to D - 1): Eligible plaque psoriasis patients sign an informed consent form and complete screening assessments to establish baseline data.
* Treatment Period (W1D1 to W9D1 ± 3 days): After baseline evaluation, eligible patients are randomized. The first dose of the study drug is administered on W1D1, with twice - daily dosing for 8 weeks. Patients return to the study center at W3D1 ± 3, W5D1 ± 3, W7D1 ± 3, W9D1 ± 3, and W11D1 ± 3 for scheduled assessments and procedures.
* Follow - up Period (W9D1 ± 3 days to W11D1 ± 3 days, within 14 days after the last dose): Adverse events and concomitant medications are collected. A final safety visit (W11D1 ± 3 days) includes additional assessments and procedures.
In summary, this trial aims to comprehensively evaluate HSK44459 cream's potential as a treatment for plaque psoriasis, while also characterizing its safety, tolerability, and PK properties in both healthy individuals and patient populations.