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NCT Number: NCT07318675

A Phase Ib Study of HW211026 Ointment in Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HW211026

Drug

Dose 1 and Dose 2

Placebo

Drug

Dose 1 and Dose 2

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: up to 28 days

    To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis

Secondary outcomes

  1. The maximum serum concentration(Cmax)

    Time frame: up to 10 days

    PK Parameter

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

    Time frame: up to 10 days

    PK Parameter

  3. The time to reach Cmax(Tmax)

    Time frame: up to 10 days

    PK Parameter

  4. The Half life(t1/2)

    Time frame: up to 10 days

    PK Parameter

Sponsors and collaborators

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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