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

NCT07676357 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Acute and Chronic Pain

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

Sponsors & Collaborators

  • Yichang Humanwell Pharmaceutical Co., Ltd., China

    collaborator INDUSTRY

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2026-06-28
Completion
2026-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676357 on ClinicalTrials.gov