RecruitingPhase 1

A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects

China80 participantsStarted 2025-12-30

Plain-language summary

This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.
✓. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².
✓. Female subjects must be non-pregnant or non-childbearing potential;
✓. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.

Exclusion criteria

✕. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;
✕. Known or suspected hypersensitivity to trial product(s) or related products;
✕. 12-lead ECG demonstrating QTcF \>450 msec or history or risk factors for QT prolongation;
✕. Blood donation of more than 200 mL within the last 6 months
✕. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;
✕. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.
✕. Previous administration with an investigational product (drug or vaccine) within 3 months;

What they're measuring

The incidence and severity of adverse events

Timeframe: from ICF signing date to Day 14 or Day 21 or Day 27

Trial details

NCT IDNCT07301333

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Yuanyuan Huang

+0518-82342973 yuanyuan.huang@hengrui.com

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