Testing HRS-2129 for pain in healthy individuals

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-2129 Following Multiple Doses Administration in Healthy Subjects

This study is testing a new drug called HRS-2129 to see if it can help manage pain in healthy people aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06742840 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-2129 in healthy subjects. Participants will receive multiple ascending doses of HRS-2129 or a placebo to assess how the drug affects pain response. The study aims to gather data on how the drug is processed in the body and its effects on pain perception. Healthy volunteers aged 18 to 55 will be recruited for this trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a body mass index between 19.0 and 28.0.

Not a fit: Patients with acute or chronic diseases affecting various body systems or those with a history of certain arrhythmias will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new pain management options for patients.

How similar studies have performed: While this approach is not widely tested, similar studies evaluating new pain management drugs have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Changsha, Hunan

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yuanyuan Huang, M.M

Conditions Pain