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

Hengrui Medicine

Status and phase

Enrolling

Phase 1

Conditions

Pain

Treatments

Drug: placebo

Drug: HRS-6257

Study type

Interventional

Funder types

Industry

Identifiers

NCT07301333

HRS-6257-101

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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;