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New pain pill HRS-6257 enters first human tests

NCT ID NCT07301333

Symptom relief Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This early-phase study is testing a new drug, HRS-6257, in 80 healthy adults to see if it is safe and how the body processes it. Participants will receive either the drug or a placebo, and researchers will monitor side effects and measure drug levels in the blood. The study also looks at how food affects the drug and includes a cold pain test to get an early read on pain response, but it is not designed to prove the drug works for pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-6257
What this could lead to
If successful, this could point toward a new oral pain medication.
What could go wrong
This is a very early Phase 1 study in healthy people, not patients. It only tests safety and how the drug moves through the body, not whether it actually relieves pain. Many drugs fail at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

80 people

The number who actually took part.

Started

Dec 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain

Contacts and locations

Locations

  • Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.