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

NCT07301333 | Recruiting Phase 1

• 1 other identifier: HRS-6257-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  from ICF signing date to Day 14 or Day 21 or Day 27

Secondary Outcomes (8)

• AUC of HRS-6257

  0 hour to 72 hour after administration

• Cmax of HRS-6257

  0 hour to 72 hour after administration

• Tmax of HRS-6257

  0 hour to 72 hour after administration

• t1/2 of HRS-6257

  0 hour to 72 hour after administration

• CL/F of HRS-6257

  0 hour to 72 hour after administration

Study Arms (2)

HRS-6257 group

EXPERIMENTAL

Drug: HRS-6257

placebo group

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

placebo

placebo group

HRS-6257 DRUG

HRS-6257

HRS-6257 group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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;
• 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;

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuanyuan Huang

CONTACT

+0518-82342973; yuanyuan.huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: December 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-11

Locations

CN (1)