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

A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis

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.

Study Overview

• Status: Recruiting
• Conditions: Actinic Keratosis (AK)
• Intervention / Treatment: Drug: HW211026; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200443
    • Recruiting
    • Shanghai Skin Disease Hospital
    • Contact: Guolong Zhang, Doctor; Phone Number: +87 021 36803156; Email: zglamu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HW211026; Single or multiple topical doses of HW211026	Drug: HW211026; Dose 1 and Dose 2
Placebo Comparator: Placebo; Single or multiple topical doses of placebo	Drug: Placebo; Dose 1 and Dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number and severity of treatment emergent adverse events (TEAEs)	To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum serum concentration(Cmax)	PK Parameter	up to 10 days
The Area Under the Curve from dosing to the time of the last measured concentration	PK Parameter	up to 10 days
The time to reach Cmax(Tmax)	PK Parameter	up to 10 days
The Half life(t1/2)	PK Parameter	up to 10 days

Collaborators and Investigators

• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Skin Diseases; Precancerous Conditions; Keratosis; Skin and Connective Tissue Diseases; Keratosis, Actinic
• Other Study ID Numbers: HW211026-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No