NCT04424251

Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Undergoing Elective Laparoscopic Surgery

A Randomized, Double-blind, Placebo-controlled, Two-stage Phase II Study Evaluating the Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	Experimental: stage I：HSK21542 0.4 μg/kg	Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
DRUG	Experimental: stage I：HSK21542 1 μg/kg	Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
DRUG	Experimental: stage I：HSK21542 0.5μg/kg	once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
DRUG	Experimental: stage I：HSK21542 1μg/kg	once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
DRUG	Experimental: stage II：HSK21542 0.5μg/kg	once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
DRUG	Experimental: stage II：HSK21542 1μg/kg	once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
DRUG	Placebo	once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

Timeline

• Start date: 2020-07-02
• Primary completion: 2020-12-07
• Completion: 2021-01-05
• First posted: 2020-06-09
• Last updated: 2024-08-26

Locations

1 site across 1 country: China