NCT06742840
Completed
Phase 1
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 enrollmentStarted: December 30, 2024Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- The incidence and severity of adverse events (AEs)
Overview
Brief Summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-2129 in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Placebo Comparator
Intervention: HRS-2129 placebo (Drug)
HRS-2129 experimental group
Experimental
Intervention: HRS-2129 (Drug)
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.)
Investigators
Study Sites (1)
Loading locations...
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