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

NCT ID: NCT07301333

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS-6257 group

Group Type EXPERIMENTAL

HRS-6257

Intervention Type DRUG

HRS-6257

placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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HRS-6257

HRS-6257

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Central Contacts

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Yuanyuan Huang

Role: CONTACT

Phone: +0518-82342973

Email: [email protected]

Other Identifiers

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HRS-6257-101

Identifier Type: -

Identifier Source: org_study_id