NCT07491146

Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain

To Evaluate the Efficacy and Safety of HSK55718 for Injection in Patients With Abdominal Postoperative Pain: a Multicenter, Randomized, Double-blind, Placebo/Positive Control Phase II Clinical Trial.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yingyong Zhou,MD,PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.

Conditions

• Pain After Abdominal Surgery

Interventions

Type	Name	Description
DRUG	Low dose HSK55718	NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours
DRUG	Medium Dose HSK55718	NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours.
DRUG	High dose HSK55718	NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours
DRUG	Morphine	NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours
DRUG	Normal saline solution	NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-10-30
• Completion: 2026-12-30
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

2 sites across 1 country: China