New pain drug HRS-2129 tested in healthy adults
NCT ID NCT06742840
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
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23 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
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Jul 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
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