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

NCT ID: NCT03698617

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-06
• Study Completion Date: 2018-07-18

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.

Conditions

Induction of General Anaesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: 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

Dose Escalation Cohorts:2.0mg/kg and 2.5mg/kg; Dose Expansion Cohorts: 2.0mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

For induction of general anesthesia

Interventions

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.

Intervention Type: DRUG

Propofol

For induction of general anesthesia

Intervention Type: DRUG

Eligibility Criteria

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.

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.

11. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The 2nd Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

Countries

China

References

Zhu Q, Luo Z, Wang X, Wang D, Li J, Wei X, Tang J, Yao S, Ouyang W, Zhang W, Zuo Y, Wang X, Liu J. Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial. Int J Clin Pharm. 2023 Apr;45(2):473-482. doi: 10.1007/s11096-022-01529-x. Epub 2023 Jan 21.

Reference Type: DERIVED

PMID: 36680620 (View on PubMed)

Other Identifiers

HSK3486-202

Identifier Type: -

Identifier Source: org_study_id