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A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486

NCT03698617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-10-09

No results posted yet for this study

Summary

This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.

Conditions

  • Induction of General Anaesthesia

Interventions

DRUG

HSK3486

For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results.

DRUG

Propofol

For induction of general anesthesia

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2016-12-06
Primary Completion
2018-06-29
Completion
2018-07-18

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 NCT03698617 on ClinicalTrials.gov