Actinic Keratosis (AK)
Conditions
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.
Interventions
DRUGHW211026
Dose 1 and Dose 2
DRUGPlacebo
Dose 1 and Dose 2
Sponsors
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | up to 28 days | To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum serum concentration(Cmax) | up to 10 days | PK Parameter |
| The Area Under the Curve from dosing to the time of the last measured concentration | up to 10 days | PK Parameter |
| The time to reach Cmax(Tmax) | up to 10 days | PK Parameter |
| The Half life(t1/2) | up to 10 days | PK Parameter |
Countries
China
Outcome results
None listed