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

NCT07318675 | Recruiting Phase 1

• 1 other identifier: HW211026-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The maximum serum concentration(Cmax)

  up to 10 days

• The Area Under the Curve from dosing to the time of the last measured concentration

  up to 10 days

• The time to reach Cmax(Tmax)

  up to 10 days

• The Half life(t1/2)

  up to 10 days

Study Arms (2)

HW211026

EXPERIMENTAL

Single or multiple topical doses of HW211026

Drug: HW211026

Placebo

PLACEBO COMPARATOR

Single or multiple topical doses of placebo

Drug: Placebo

Interventions

HW211026 DRUG

Dose 1 and Dose 2

HW211026

Placebo DRUG

Dose 1 and Dose 2

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, 200443, China

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 6, 2026
• Study Start: December 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)