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

NCT06619392 | Completed Phase 1

• 1 other identifier: HRS-2129-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  from ICF signing date to day 28 since last dose

Secondary Outcomes (10)

• Pharmacokinetic parameter of HRS-2129: Cmax

  0 hour to 216 hour after administration

• Pharmacokinetic parameter of HRS-2129: AUC0-t

  0 hour to 216 hour after administration

• Pharmacokinetic parameter of HRS-2129: AUC0-inf

  0 hour to 216 hour after administration

• Pharmacokinetic parameter of HRS-2129: Tmax

  0 hour to 216 hour after administration

• Pharmacokinetic parameter of HRS-2129: t1/2

  0 hour to 216 hour after administration

Study Arms (5)

Treatment at dose level 1

EXPERIMENTAL

Drug: HRS-2129; Drug: HRS-2129 Placebo

Treatment at dose level 2

EXPERIMENTAL

Drug: HRS-2129; Drug: HRS-2129 Placebo

Treatment at dose level 3

EXPERIMENTAL

Drug: HRS-2129; Drug: HRS-2129 Placebo

Treatment at dose level 4

EXPERIMENTAL

Drug: HRS-2129; Drug: HRS-2129 Placebo

Treatment at dose level 5

EXPERIMENTAL

Drug: HRS-2129; Drug: HRS-2129 Placebo

Interventions

HRS-2129 DRUG

HRS-2129

Treatment at dose level 1; Treatment at dose level 2; Treatment at dose level 3; Treatment at dose level 4; Treatment at dose level 5

HRS-2129 Placebo DRUG

HRS-2129 Placebo

Treatment at dose level 1; Treatment at dose level 2; Treatment at dose level 3; Treatment at dose level 4; Treatment at dose level 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 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;
• Subject with a history of torsade de pointes, symptomatic ventricular 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;
• Drink more than 14 units of alcohol per week on average;
• Drink excessive tea, coffee or caffeinated beverages within 3 months before screening;
• 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;
• Subject who has special requirements for diet and cannot follow a unified diet;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-2129 for dose escalation

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: October 17, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

CN (1)