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CompletedNCT06619392Updated Mar 5, 2025

A Single Dose Escalation Trial of HRS-2129 in Healthy Subjects

A Phase 1 interventional study of HRS-2129 and HRS-2129 Placebo in Pain, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 cold pain test.
  7. Subject who voluntarily signs the informed consent.

Exclusion criteria

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 the following abnormalities: aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatine value exceeds the upper limit of the normal range, QTcF > 450 ms, hyperpotassemia or hypopotassemia;
  3. Subject with a history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
  4. Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;
  5. 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;
  6. Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration;
  7. Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study;
  8. 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;
  9. 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;
  10. Donate blood/blood loss ≥ 400 mL within 3 months before screening;
  11. Subject who smoked more than 5 cigarettes per day on average within 3 months before screening;
  12. Drink more than 14 units of alcohol per week on average;
  13. Drink excessive tea, coffee or caffeinated beverages within 3 months before screening;
  14. 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;
  15. Subject who has special requirements for diet and cannot follow a unified diet;
  16. Subject with clinical significant abnormalities in medical examination;
  17. Subject with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody;
  18. Subject with a history of drug abuse or with a positive result for drug abuse test;
  19. Alcohol test result is positive;
  20. 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;
  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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Treatment at dose level 1

    Drug: HRS-2129 · Drug: HRS-2129 Placebo

  • Experimental
    Treatment at dose level 2

    Drug: HRS-2129 · Drug: HRS-2129 Placebo

  • Experimental
    Treatment at dose level 3

    Drug: HRS-2129 · Drug: HRS-2129 Placebo

  • Experimental
    Treatment at dose level 4

    Drug: HRS-2129 · Drug: HRS-2129 Placebo

  • Experimental
    Treatment at dose level 5

    Drug: HRS-2129 · Drug: HRS-2129 Placebo

Interventions

  • DrugHRS-2129

    HRS-2129

  • DrugHRS-2129 Placebo

    HRS-2129 Placebo

06

What researchers measure

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: from ICF signing date to day 28 since last dose

Secondary outcomes

  1. Pharmacokinetic parameter of HRS-2129: Cmax

    Time frame: 0 hour to 216 hour after administration

  2. Pharmacokinetic parameter of HRS-2129: AUC0-t

    Time frame: 0 hour to 216 hour after administration

  3. Pharmacokinetic parameter of HRS-2129: AUC0-inf

    Time frame: 0 hour to 216 hour after administration

  4. Pharmacokinetic parameter of HRS-2129: Tmax

    Time frame: 0 hour to 216 hour after administration

  5. Pharmacokinetic parameter of HRS-2129: t1/2

    Time frame: 0 hour to 216 hour after administration

  6. Pharmacokinetic parameter of HRS-2129: CL/F

    Time frame: 0 hour to 216 hour after administration

  7. Pharmacokinetic parameter of HRS-2129: Vz/F

    Time frame: 0 hour to 216 hour after administration

  8. Electrocardiogram measurement: QTcF interval

    Time frame: 90 minute predose to 48 hour after administration

  9. Pain detection threshold for the Thermode Cold Test

    Time frame: 0 hour to 12 hour after administration

  10. Pain tolerance time for the Thermode Cold Test

    Time frame: 0 hour to 12 hour after administration

07

Study locations

1 site
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410013, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06619392
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Oct 17, 2024
Primary completion
Jan 20, 2025
Completion
Jan 20, 2025
Last update
Mar 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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