Clinical trial · Interventional
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
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
NCT07318675CI-TRIAL-00100155recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis (AK) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HW211026 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HW211026
- description
- Single or multiple topical doses of HW211026
- interventionNames
- Drug: HW211026
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Single or multiple topical doses of placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The number and severity of treatment emergent adverse events (TEAEs)
- timeFrame
- up to 28 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.