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

NCT04470154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2022-08-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470154 on ClinicalTrials.gov