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Completed

NCT Number: NCT03698617

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The 2nd Affiliated Hospital of WMU

Wenzhou, Zhejiang, 325027, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatients required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
  • Males or females, aged ≥ 18 and ≤ 65 years old;
  • Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
  • ASA grade I~II;
  • Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.

Exclusion criteria

  • Patients were contraindicated in general anesthesia.;
  • Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
  • Patients in receipt of any investigational drug within 30 days before screening.
  • Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
  • Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
  • The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
  • Abnormal laboratory results consisting of any of the following: :
  • AST and ALT≥ 2×ULN; 2)TBIL≥ 1.5×ULN; 3)Hb≤ 90g/L; 4)ANC≤1.5×109/L; 5) PLT≤80×109/L; 6) serum creatinine≥ 1.5×ULN.
  • Patients with a history of drug or ethanol abuse with the past 3 months. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients. . 10. 10. Patients with a positive Allen 's test who collected arterial blood for PK study.
  • Patients with respiratory management difficulties. 12. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

Treatment and study plan

HSK3486

Drug

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.

Propofol

Drug

For induction of general anesthesia

Primary outcomes

  1. The success rate of induction of general anesthesia

    Time frame: during induction of general anesthesia on day 1

    To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement.

Secondary outcomes

  1. Time from start of IMP administration to loss of eyelash reflex

    Time frame: during induction of general anesthesia on day 1

  2. Time from start of IMP administration to loss of consciousness

    Time frame: during induction of general anesthesia on day 1

  3. Time from start of IMP administration to intubation and the intubation reaction

    Time frame: during induction of general anesthesia on day 1

  4. Mini-Mental State Examination (MMSE) total scores(0-30) by time point

    Time frame: Pre-dose to 48 hours post-dose

    Change from baseline in Mini-Mental State Examination (MMSE) total score

  5. change from baseline in blood pressure (systolic, diastolic and mean arterial pressure)

    Time frame: pre-dose to 20 minutes post-dose

    safety endpoits

  6. change from baseline in heart rate

    Time frame: pre-dose to 20 minutes post-dose

    safety endpoits

  7. change from baseline in arterial oxygen saturation

    Time frame: pre-dose to 20 minutes post-dose

    safety endpoits

  8. Number of patients with adverse events

    Time frame: Pre-dose to 48 hours post-dose

    safety endpoits

Sponsors and collaborators

Lead sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.