Single and multiple oral doses of HRS-6257 in healthy adults

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

This phase 1 study will test single and repeated oral doses of HRS-6257 in healthy adults to see if the drug is safe, how the body handles it, and whether food affects absorption.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07301333 on ClinicalTrials.gov

What this trial studies

This randomized, single-blind, placebo-controlled, two-part phase 1 trial gives single and multiple oral doses of HRS-6257 to healthy volunteers to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect. Part A includes single-dose cohorts and Part B includes multiple-dose cohorts, each with placebo control and scheduled clinical and laboratory monitoring. Eligible volunteers are screened for age, weight, BMI, ECG, and absence of significant medical history or recent medication use. The trial is conducted at Third Xiangya Hospital of Central South University in Changsha, Hunan, China and follows standard phase 1 safety and PK sampling procedures.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with BMI 19–28 kg/m² (males ≥50 kg, females ≥45 kg), non-pregnant, without significant medical conditions, and willing to comply with study procedures are eligible.

Not a fit: People with active pain seeking immediate therapy, pregnant or childbearing individuals, children, those outside the age/BMI range, or anyone with significant medical problems or recent drug use would not be expected to benefit from participating.

Why it matters

Potential benefit: If successful, HRS-6257 could lead to a new oral pain treatment with a defined safety and dosing profile.

How similar studies have performed: Single- and multiple-dose phase 1 studies are the standard early approach for new pain drugs and have enabled many candidates to advance, but HRS-6257's clinical efficacy has not yet been demonstrated.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Changsha, Hunan

• Third Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Yuanyuan Huang

Conditions: Pain