A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.

NCT ID: NCT07318675

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-03-31

Brief Summary

This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.

Conditions

Actinic Keratosis (AK)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HW211026

Single or multiple topical doses of HW211026

Group Type: EXPERIMENTAL

HW211026

Intervention Type: DRUG

Dose 1 and Dose 2

Placebo

Single or multiple topical doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose 1 and Dose 2

Interventions

HW211026

Dose 1 and Dose 2

Intervention Type: DRUG

Placebo

Dose 1 and Dose 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
• A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal).
• Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study.

Exclusion Criteria

• Subjects with any of the following conditions within the treatment field：

• Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns;
• Maximum diameter of a single lesion > 2 cm；
• History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；
• Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.
• treatment field falls within any of the following locations:

• Presence of incompletely healed wounds within a 5 cm radius of the treatment field;
• Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field.
• Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.
• Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Skin Disease Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guolong Zhang, Doctor

Role: primary

zglamu@163.com

+87 021 36803156

Other Identifiers

HW211026-102

Identifier Type: -

Identifier Source: org_study_id