Phase I Trial Evaluating Safety and Pharmacokinetics of YR001 Topical Ointment in Healthy Chinese Adults

What this Trial Is About

Researchers are studying the safety, local tolerability, and pharmacokinetics of YR001 Topical Ointment in healthy Chinese adults aged 18 to 65 years. This Phase I trial is the first of its kind in China and aims to understand how the ointment is absorbed and processed in the body after single and multiple applications. Participants receiving YR001 ointment will be compared with those receiving a matching placebo to assess safety and tolerability. Participants will be assigned to one of four groups receiving YR001 ointment or placebo applied to about 10% or 20% of their body surface area. The ointment is applied either once or multiple times daily over several days, depending on the group. Safety will be monitored before proceeding to multiple-dose administration. This includes single topical application on Day 1 followed by multiple doses from Day 3 to Day 9 or multiple doses from Day 1 to Day 7 with varying frequencies. During the study, participants will stay in the clinical unit for defined periods and undergo comprehensive safety evaluations including physical exams, vital signs, laboratory tests, ECGs, and assessments of the skin at the application site. Blood samples will be taken at scheduled times to study the drugs pharmacokinetics. The total participation time lasts up to about 30 days, during which adverse events and tolerability will be closely monitored.

An Early-stage Clinical Trial to Evaluate the Safety, Absorption, and Disposition of YR001 Ointment Following Topical Application on the Skin of Healthy Chinese Subjects