RecruitingPhase 1NCT07301333

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

A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Pain

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

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 Criteria7

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;