Phase 1b Study of HW211026 Ointment to Assess Safety and Effects in Adults with Actinic Keratosis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes and responds to HW211026 ointment in patients with actinic keratosis. This is a phase Ib study focusing on single or multiple topical applications of the ointment in adults with this skin condition. The study aims to understand both the pharmacokinetic and pharmacodynamic properties of the treatment compared to a placebo. Participants will receive either HW211026 ointment or a placebo applied to the skin in single or multiple doses. The study is randomized and double-blinded, meaning neither the participants nor the researchers know who receives the active ointment or placebo. The treatment area is a 100 cm field on the face, excluding sensitive regions such as lips, eyelids, and nostrils. Participants are asked to avoid direct sun or UV exposure on the treated area during the study. During the study, participants will be monitored for any treatment-emergent adverse events up to 28 days. Blood samples will be collected up to 10 days to measure drug concentration levels and how long the drug stays in the body. Researchers will also evaluate the severity and number of side effects, with ongoing safety assessments. The total study duration includes treatment and follow-up periods to ensure comprehensive monitoring of effects and tolerability.

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