Safety, Tolerability, and Pharmacokinetics of Multiple-Dose RFUS-949 in Healthy Chinese Participants

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial. The primary objective is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RFUS-949 tablets following multiple oral doses in healthy Chinese adult participants (aged 18 to 45 years). The study is designed to explore the multiple-dose characteristics of the investigational drug. It consists of a once-daily (QD) dosing cohort and three twice-daily (BID) dose escalation cohorts. Participants will receive multiple oral doses of either RFUS-949 or a matching placebo in a fasting state for 6 consecutive days, with rigorous safety monitoring and PK blood sampling throughout the study period.

NCT Number	NCT07676357
Lead Sponsor	The Affiliated Hospital of Qingdao University Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China
Conditions	Acute and Chronic Pain
Enrollment	28 participants
Start Date	2026-01-22
Primary Completion	2026-06-28 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30