A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT07301333
- Run by
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- People needed
- 80
- Starts
- 2025-12-30
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Third Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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