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

Phase 2 Completed 124 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-07-02
Primary completion: 2020-12-07
Completion: 2021-01-05

Publications

Zhong Y, Wang H, Yan M, Yang M, Zhang J, Nan L, Wang Z, Yang J, Wu J, Guo Q, Hu X, Xu H, Xu Q, Wang D. Efficacy and safety of peripherally-restricted kappa-opioid receptor agonist-HSK21542 for postoperative analgesia in patients undergoing laparoscopic abdominal surgery: a randomized, placebo-controlled phase 2 trial. Front Med (Lausanne). 2025 Jul 24;12:1604790. doi: 10.3389/fmed.2025.1604790. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSK21542	Peptide	0.2 ug/kg	Intravenous
Subject	HSK21542	Peptide	0.5 ug/kg	Intravenous
Subject	HSK21542	Peptide	1 ug/kg	Intravenous

Indications

No indication recorded.