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Recruiting Phase 2

A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery

NCT07533786 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-05-22
Last updated
2026-05-28

Condition(s) studied

Pain After Surgery

Investigational drug(s) / intervention(s)

HSK55718 dose level1HSK55718 dose level2HSK55718 dose level 3 →Placebo controlmorphine →

HSK55718 dose level1: Patients administrated with HSK55718 at dose level 1

HSK55718 dose level2: Patients administrated with HSK55718 at dose level 2

HSK55718 dose level 3: Patients administrated with HSK55718 at dose level 3

Placebo control: Patients administrated with placebo

morphine: Patients administrated with morphine

Study summary

This is a multi-center, randomized, double-blind, double-dummy, placebo/active-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years old, regardless of gender; * 18 kg/m2≤BMI≤30 kg/m2; * American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; * Accept abdominal surgery under general anesthesia; * Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; * Fully understand and voluntarily participate this trial, and sign the informed consent form; Exclusion Criteria: * A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria. * Clinically significant abnormalities in laboratory tests during the screening period. * A history of severe drug allergy or known allergy to the investigational drug. * Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization. * Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization. * A history of drug abuse, substance abuse, and/or alcohol abuse within the past year. * Pregnant or lactating women. * Participation in another drug clinical trial within 3 months prior to the screening period. * Presence of any sensory dysfunction. * Presence of any painful physical condition. * Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Primary outcome measure(s)

  • Sum of Pain Intensity Differences (SPID) — 24 hours

Trial sites (2)

FacilityCityRegionStatus
The Third Xiangya Hospital of Central South University Changsha Hunan Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07533786 on ClinicalTrials.gov ↗ ← All trials in China