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

Phase 2

Completed

• Conditions: Induction of General Anaesthesia
• Interventions: Drug: HSK3486; Drug: Propofol

• Registration Number: NCT03698617
• Lead Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12-06
• Primary Completion: 2018-06-29
• Study Completion: 2018-07-18
• Status Verified: 2018-09
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-10-05
• Last Update Submitted: 2018-10-05
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. 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 ;.
2. Males or females, aged ≥ 18 and ≤ 65 years old;
3. Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
4. ASA grade I~II;
5. 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.

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Exclusion Criteria

1. Patients were contraindicated in general anesthesia.;
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
3. Patients in receipt of any investigational drug within 30 days before screening.
4. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
5. Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
6. 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.
7. Abnormal laboratory results consisting of any of the following: :

1. 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.

8. 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.

9. 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HSK3486	HSK3486	Dose Escalation Cohort: 0.1 mg/kg, 0.2 mg/kg, 0.3mg/kg 0.4 mg/kg 0.5 mg/kg, 0.6 mg/kg, 0.7mg/kg, 0.8 mg/kg Dose Expansion Cohort: 0.3 mg/kg and 0.5 mg/kg.
Propofol	Propofol	Dose Escalation Cohorts:2.0mg/kg and 2.5mg/kg; Dose Expansion Cohorts: 2.0mg/kg

Primary Outcome Measures

Name	Time	Method
The success rate of induction of general anesthesia	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 Outcome Measures

Name	Time	Method
Time from start of IMP administration to loss of eyelash reflex	during induction of general anesthesia on day 1
change from baseline in blood pressure （systolic, diastolic and mean arterial pressure)	pre-dose to 20 minutes post-dose	safety endpoits
change from baseline in arterial oxygen saturation	pre-dose to 20 minutes post-dose	safety endpoits
Time from start of IMP administration to intubation and the intubation reaction	during induction of general anesthesia on day 1
Number of patients with adverse events	Pre-dose to 48 hours post-dose	safety endpoits
Time from start of IMP administration to loss of consciousness	during induction of general anesthesia on day 1
Mini-Mental State Examination (MMSE) total scores(0-30) by time point	Pre-dose to 48 hours post-dose	Change from baseline in Mini-Mental State Examination (MMSE) total score
change from baseline in heart rate	pre-dose to 20 minutes post-dose	safety endpoits

Trial Locations

Locations (1)

The 2nd Affiliated Hospital of WMU; 🇨🇳 Wenzhou, Zhejiang, China