NCT04999787

A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study. About 90 liver disease subjects with moderate or above pruritus are planned to be enrolled. They will be randomized to two dose groups (0.3 μg/kg and 0.6 μg/kg) and a placebo control group at a 1:1:1 ratio, with about 30 subjects in each group.

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	HSK21542	HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-08-11
• Last updated: 2022-11-02

Locations

1 site across 1 country: China