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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Shanghai Skin Disease Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2025-12-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: HW211026
Single or multiple topical doses of HW211026
Placebo_comparator: Placebo
Single or multiple topical doses of placebo
Related Therapeutic Areas
Sponsors
Leads: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.