a multiple ascending dose trial of hrs-2129 in healthy subjects

Conditions: Pain

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hrs-2129 in healthy subjects.


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.