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A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04033939
Recruitment Status : Completed
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Haisco Pharmaceutical Group Co., Ltd. ( Sichuan Haisco Pharmaceutical Group Co., Ltd )

Brief Summary:

This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection.

Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).


Condition or disease Intervention/treatment Phase
Anesthesia Sedation Drug: HSK3486 Drug: Propofol Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Following Screening, subjects who meet the inclusion/exclusion criteria will be assigned a subject number in the order in which they are enrolled in the study. The subject number will determine the allocation of treatment as per the randomization list which will be generated by INCResearch Australia Pty Ltd and provided to the pharmacist. Cohorts 1 and 2 are a placebo controlled design, with open-labelling for the sentinel subjects and double-blind thereafter. Cohorts 3 to 8 are an open-label, positive controlled design.
Primary Purpose: Treatment
Official Title: A Phase I, Placebo and Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Injection of HSK3486 in Healthy Subjects
Actual Study Start Date : April 13, 2014
Actual Primary Completion Date : November 11, 2014
Actual Study Completion Date : May 4, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: HSK3486-01
Randomized to receive HSK3486 (0.016mg/kg,0.064mg/kg )as a single IV injection. HSK3486-01 was blinded.(2 HSK3486-01: 1 Placebo-01)
Drug: HSK3486
Placebo Comparator: Placebo-01
Randomized to receive placebo (0.016mg/kg,0.064mg/kg )as a single IV injection. placebo-01 was blinded.(2 HSK3486-01: 1 Placebo-01)
Drug: Placebo
Experimental: HSK3486-02
Randomized to receive either HSK3486(0.128mg/kg,0.192mg/kg,0.288mg/kg,0.432mg/kg,0.540mg/kg,0.648mg/kg,0.810mg/kg) as a single IV injection. HSK3486-02 was open-label.(5 HSK3486-02: 1 propofol-02)
Drug: HSK3486
Active Comparator: Propofol-02
Randomized to receive propofol (2.5mg/kg) as a single IV injection. Propofol-02 was open-label.(5 HSK3486-02: 1 propofol-02)
Drug: Propofol



Primary Outcome Measures :
  1. Safety by measurement of Adverse Events [ Time Frame: First dose of study drug on day 1 ]

Secondary Outcome Measures :
  1. Median effective dose (ED50) [ Time Frame: From first dose of study drug until fully alert on day 1 ]
  2. Peak concentration (Cmax) [ Time Frame: From the start of administration to 48 hours after administration ]
  3. Time to plasma peak concentration(Tmax) [ Time Frame: From the start of administration to 48 hours after administration ]
  4. Terminal elimination half life (t1/2z) and mean residence time (MRT) [ Time Frame: From the start of administration to 48 hours after administration ]
  5. Mean residence time (MRT) [ Time Frame: From the start of administration to 48 hours after administration ]
  6. Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf) [ Time Frame: From the start of administration to 48 hours after administration ]
  7. Total clearance (CL) [ Time Frame: From the start of administration to 48 hours after administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, aged 18 - 49 years (inclusive).
  • In general good health without clinically significant (CS) medical history.
  • American Society of Anesthesiologists (ASA) Physical Status Classification of I or II.
  • Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
  • Negative screen for drugs of abuse, alcohol, Hepatitis B surface antigen (HBs-Ag), Hepatitis C Virus antibody (HCV-Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1.
  • Normal or non-clinically significant (NCS) findings on a physical examination, 12-lead electrocardiogram (ECG) and vital signs (respiration rate between 12 and 20 breaths per minute, blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute, temperature between 35.8°C and 37.5°C and pulse oximetry values > 95% on room air).
  • Clinical laboratory values within the normal limits as defined by the clinical laboratory samples, unless the Principal Investigator (PI) decided that out-of-range values were not CS.
  • Able to provide written informed consent.
  • Willing and able to follow study instructions and likely to complete all study requirements.
  • Suitable venous and arterial access.

Exclusion Criteria:

  • History of allergy or sensitivity to: propofol, components of Fresofol 1% MCT/LCT propofol, or HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine.
  • History of CS problems with general anesthesia.
  • Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening.
  • History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months.
  • Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of simple analgesics such as paracetamol and oral non-steroidal antiinflammatory agents.
  • Standard donation of blood within 30 days of the study.
  • Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study.
  • Receipt of any investigational study drug within 30 days prior to screening.
  • Unable to fast for the 6 hours prior to Investigational Product administration.
  • Clinically significant (as judged by the Investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit.
  • Anticipated need for surgery or hospitalization during the study.
  • Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia.
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Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd
ClinicalTrials.gov Identifier: NCT04033939    
Other Study ID Numbers: HSK3486Australia-01
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics