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Trial of HSK44459 Cream for the Management Plaque Psoriasis

NCT07623486 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

HSK44459 Cream

HSK44459 Cream

DRUG

Vehicle

HSK44459 Vehicle

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-22
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623486 on ClinicalTrials.gov