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New pain drug HRS-2129 tested in healthy adults

NCT ID NCT06742840

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 1 study tested the safety and tolerability of HRS-2129, a new drug for pain, in 23 healthy adults aged 18 to 55. Researchers measured side effects and how the body processes the drug, along with pain responses to cold and heat. Because it was only in healthy volunteers, it does not yet show if the drug helps people with chronic 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-2129
What this could lead to
If successful, this could point toward a new pain treatment option.
What could go wrong
This is an early Phase 1 study in healthy people, not patients. It only tests safety and basic pain response, so it may not work for real pain conditions.

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

23 people

The number who actually took part.

Started

Dec 2024

Finished

Jul 2025

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. Age: 18 to 55 years old (inclusive); 2. Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 \~ 28.0 kg/m2 (inclusive); 3. Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose; 4. Female subjects: non-pregnant or non-lactating; 5. The skin to receive pain stimuli has no wound or derma disease; 6. Subject who is willing to accept pain test; 7. Subject who voluntarily signs the informed consent. Exclusion Criteria: 1. Subject who suffers from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; 2. Subject with a history of torsade de pointes, symptomatic or multigenic or frequent or require medical treatment arrhythmia, or personal or family history of short QT syndrome or long QT syndrome; 3. Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution; 4. Subject who underwent major surgery within 6 months prior to screening, or received surgery that may significantly affect the pharmacokinetics or safety evaluation of the IMP, or who plans to undergo surgery during the study period; 5. Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration; 6. Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study; 7. Subject who used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or who plans to receive other drug treatments during the study; 8. Subject who has participated in clinical trials and received experimental drugs within 3 months before screening, or plans to participate in other clinical trials during this study; 9. Donate blood/blood loss ≥ 400 mL within 3 months before screening; 10. Subject who smoked more than 5 cigarettes per day on average within 3 months before screening; 11. Drink more than 14 units of alcohol per week on average; 12. Drink excessive tea, coffee or caffeinated beverages within 3 months before screening; 13. Consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration; 14. Subject who has special requirements for diet and cannot follow a unified diet; 15. Subject with clinical significant abnormalities in medical examination; 16. Subject with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody; 17. Subject with a history of drug abuse or with a positive result for drug abuse test; 18. Alcohol test result is positive; 19. Subject who has difficulty in swallowing, or venous blood collection, or who cannot tolerate venipuncture, or who has a history of fainting of needle or blood; 20. Subject who is judged to have suicidal ideation or suicidal behavior by mental state assessment; 21. Subject may not be able to complete the study due to other reasons or the investigators considers that he is not suitable for inclusion.

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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.

Contacts and locations

Locations

  • The 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.