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.
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.
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；
Parallel
HW211026
DrugDose 1 and Dose 2
Placebo
DrugDose 1 and Dose 2
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
The maximum serum concentration(Cmax)
PK Parameter
The Area Under the Curve from dosing to the time of the last measured concentration
PK Parameter
The time to reach Cmax(Tmax)
PK Parameter
The Half life(t1/2)
PK Parameter
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