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

Shandong Suncadia Medicine Co., Ltd.1 site in 1 country23 target enrollmentDecember 30, 2024

ConditionsPain

InterventionsHRS-2129 placebo HRS-2129

DrugsHRS-2129 HRS-2129 placebo

Overview

Phase: Phase 1
Intervention: HRS-2129 placebo
Conditions: Pain
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 23
Locations: 1
Primary Endpoint: The incidence and severity of adverse events (AEs)
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 30, 2024

End Date

July 2, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18 to 55 years old (inclusive);
•Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 \~ 28.0 kg/m2 (inclusive);
•Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose;
•Female subjects: non-pregnant or non-lactating;
•The skin to receive pain stimuli has no wound or derma disease;
•Subject who is willing to accept pain test;
•Subject who voluntarily signs the informed consent.

Exclusion Criteria

•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;
•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;
•Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;
•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;
•Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration;
•Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study;
•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;
•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;
•Donate blood/blood loss ≥ 400 mL within 3 months before screening;
•Subject who smoked more than 5 cigarettes per day on average within 3 months before screening;

Arms & Interventions

HRS-2129 placebo group

Intervention: HRS-2129 placebo

HRS-2129 experimental group

Intervention: HRS-2129

Outcomes

Primary Outcomes

The incidence and severity of adverse events (AEs)

Time Frame: From ICF signing date to Day 41.

Secondary Outcomes

Cold Pain detection threshold for the Thermode Cold Test(Day 1 to Day 15.)
Heat Pain detection threshold for the Thermode Heat Test(Day 1 to Day 15.)
Pain tolerance time for the Cold Pain Test(Day 1 to Day 15.)
Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses(From ICF signing date to Day 15.)
Time to reach maximum plasma concentration (Tmax) of HRS-2129(0 hour to 216 hours after administration.)
Terminal half-life (t1/2)(0 hour to 216 hours after administration.)
Maximum plasma concentration (Cmax) of HRS-2129(0 hour to 216 hours after administration.)
Apparent clearance (CL/F) of HRS-2129(0 hour to 216 hours after administration.)
Apparent volume of distribution (Vz/F) of HRS-2129(0 hour to 216 hours after administration.)