NCT04470154 - A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HSK21542 Injection in Subjects Undergoing Hemodialysis | Biotech Hunter

Enrollment

131

Participants

Timeline

Start Date

August 10, 2020

Primary Completion Date

October 28, 2021

Study Completion Date

October 28, 2021

Conditions

Uremic Pruritus

Interventions

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

Trial Locations (1)

Guizhou Medical University Affiliated Hospital, Guiyang

All Listed Sponsors

lead

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY