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Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Undergoing Elective Laparoscopic Surgery

NCT04424251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-08-26

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.

Conditions

  • Analgesia

Interventions

DRUG

Experimental: stage I：HSK21542 0.4 μg/kg

Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations

DRUG

Experimental: stage I：HSK21542 1 μg/kg

Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations

DRUG

Experimental: stage I：HSK21542 0.5μg/kg

once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

DRUG

Experimental: stage I：HSK21542 1μg/kg

once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

DRUG

Experimental: stage II：HSK21542 0.5μg/kg

once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

DRUG

Experimental: stage II：HSK21542 1μg/kg

once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

DRUG

Placebo

once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2020-12-07
Completion
2021-01-05

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04424251 on ClinicalTrials.gov