Trial of HSK44459 Cream for the Management Plaque Psoriasis

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.

NCT Number	NCT07623486
Lead Sponsor	Haisco Pharmaceutical Group Co., Ltd.
Conditions	Psoriasis
Enrollment	180 participants
Start Date	2026-05-22
Primary Completion	2027-03 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-08