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ACTIVE NOT RECRUITING
NCT07676357
PHASE1

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

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of RFUS-949 Tablets in Healthy Chinese Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-01-22

Completion Date

2026-08-01

Last Updated

2026-06-30

Healthy Volunteers

Yes

Interventions

DRUG

RFUS-949

RFUS-949 is formulated as an oral tablet, available in 50 mg and 200 mg strengths.

DRUG

Placebo

Matching placebo tablets

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China