A Phase Ib Study of HW211026 Ointment in Patients With Ac... | NCT07318675

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

NCT07318675

Sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Status

Recruiting

Last Update Posted

Jan 6, 2026Actual

Enrollment

40Estimated

Phase

Phase 1

Conditions

Actinic Keratosis (AK)

Interventions

HW211026
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 25, 2025Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Dec 16, 2025

First Submission Date that Met QC Criteria

Jan 4, 2026

First Posted Date

Jan 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2026

Last Update Posted Date

Jan 6, 2026Actual

Label	Type	Description	Intervention Names
HW211026	Experimental	Single or multiple topical doses of HW211026	Drug: HW211026
Placebo	Placebo Comparator	Single or multiple topical doses of placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
HW211026	Drug	Dose 1 and Dose 2	HW211026
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases