Clinical trial NCT06742840: A Multiple Ascending Dose Trial of HRS-2129 in Healthy Subjects
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-2129 Following Multiple Doses Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: The incidence and severity of adverse events (AEs)
timeFrame: From ICF signing date to Day 39.
measure: The incidence and severity of adverse events (AEs)
timeFrame: From ICF signing date to Day 41.
Secondary outcomes:
measure: Cold Pain detection threshold for the Thermode Cold Test
timeFrame: Day 1 to Day 12.
measure: Cold Pain detection threshold for the Thermode Cold Test
timeFrame: Day 1 to Day 15.
measure: Heat Pain detection threshold for the Thermode Heat Test
timeFrame: Day 1 to Day 12.
measure: Heat Pain detection threshold for the Thermode Heat Test
timeFrame: Day 1 to Day 15.
measure: Pain tolerance time for the Cold Pain Test
timeFrame: Day 1 to Day 12.
measure: Pain tolerance time for the Cold Pain Test
timeFrame: Day 1 to Day 15.
measure: Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: From ICF signing date to Day 13.
measure: Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
timeFrame: From ICF signing date to Day 15.
measure: Time to reach maximum plasma concentration (Tmax) of HRS-2129
timeFrame: 0 hour to 216 hours after administration.
measure: Terminal half-life (t1/2)
timeFrame: 0 hour to 216 hours after administration.
measure: Maximum plasma concentration (Cmax) of HRS-2129
timeFrame: 0 hour to 216 hours after administration.
measure: Apparent clearance (CL/F) of HRS-2129
timeFrame: 0 hour to 216 hours after administration.
measure: Apparent volume of distribution (Vz/F) of HRS-2129
timeFrame: 0 hour to 216 hours after administration.
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: