A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HSK21542 Injection in Subjects Undergoing Hemodialysis

Phase 2 Completed 131 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-center, randomized, double-blind, placebo-controlled phase II clinical trial. The main objective is to evaluate the safety, pharmacokinetics, and efficacy of HSK21542 injection in subjects undergoing hemodialysis

Timeline

Start: 2020-08-10
Primary completion: 2021-10-28
Completion: 2021-10-28

Publications

Pan M, Wang G, Zhou L, Xu Y, Yao L, Wu C, Mei C, Zhao Z, Sun D, Guan T, Chen Q, Shi M, Xu H, Zeng W, Li F, Yan R, Liu BC. Safety and effectiveness of HSK21542 for hemodialysis patients: a multiple ascending dose study. Front Pharmacol. 2023 Oct 9;14:1203642. doi: 10.3389/fphar.2023.1203642. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSK21542	Peptide	0.05 ug/kg	Intravenous
Subject	HSK21542	Peptide	0.15 ug/kg	Intravenous
Subject	HSK21542	Peptide	0.3 ug/kg	Intravenous
Subject	HSK21542	Peptide	0.6 ug/kg	Intravenous
Subject	HSK21542	Peptide	0.8 ug/kg	Intravenous

Indications

No indication recorded.