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

NCT03698617 | Completed Phase 2

• 1 other identifier: HSK3486-202
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The success rate of induction of general anesthesia

  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.

  during induction of general anesthesia on day 1

Secondary Outcomes (8)

• Time from start of IMP administration to loss of eyelash reflex

  during induction of general anesthesia on day 1

• Time from start of IMP administration to loss of consciousness

  during induction of general anesthesia on day 1

• Time from start of IMP administration to intubation and the intubation reaction

  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 blood pressure （systolic, diastolic and mean arterial pressure)

  pre-dose to 20 minutes post-dose

Study Arms (2)

HSK3486

EXPERIMENTAL

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.

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

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.

HSK3486

Propofol DRUG

For induction of general anesthesia

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

The 2nd Affiliated Hospital of WMU

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

• 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.

  PMID: 36680620 DERIVED

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 9, 2018
• Study Start: December 6, 2016
• Primary Completion: June 29, 2018
• Study Completion: July 18, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-09

Locations

CN (1)