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NCT Number: NCT07301333

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Guoping Yang

PRINCIPAL_INVESTIGATOR

Saiying Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HRS-6257

Drug

HRS-6257

Placebo

Drug

placebo

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: from ICF signing date to Day 14 or Day 21 or Day 27

Secondary outcomes

  1. AUC of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  2. Cmax of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  3. Tmax of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  4. t1/2 of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  5. CL/F of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  6. Vz/F of HRS-6257

    Time frame: 0 hour to 72 hour after administration

  7. Pain tolerance time for the Cold Pain Test

    Time frame: Day 1 to Day 1 or Day 14

  8. Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses

    Time frame: from ICF signing date to Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanyuan Huang

CONTACT

[email protected]

+0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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