NCT04470154

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a multicenter study, which is divided into two stages. The first stage is a dose escalation, randomized, double-blind, placebo-controlled study of multiple intravenous administration within one week in hemodialysis subjects. The second stage is a randomized, double-blind, placebo-controlled study of Administration for 12 weeks in hemodialysis subjects with moderate or severe pruritus. In the second stage, consist of a Screening Visit, a 7-day Run-in Period, a 12 week Double-blind Treatment Period, and a 2-week Discontinuation Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 8 to 28 days prior to randomization to assess eligibility.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Stage I:HSK21542 0.05 μg/kg	Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
DRUG	Stage I:HSK21542 0.15 μg/kg	Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
DRUG	Stage I:HSK21542 0.30 μg/kg	Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
DRUG	Stage I:HSK21542 0.80 μg/kg	Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
DRUG	Stage II:HSK21542 0.3 μg/kg	Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group
DRUG	Stage II:HSK21542 0.6 μg/kg	Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2020-07-14
• Last updated: 2022-08-09

Locations

1 site across 1 country: China