An Open Label, Single-Center, Single Dose Combination of HSK3486 and Etomidate Intravenous Bolus Injection to Determine the Safety, Pharmacodynamics and Pharmacokinetics for Induction of Anesthesia in Healthy Male Subjects

Phase 1

• Conditions: Anesthesia; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12616001620415
• Lead Sponsor: Sichuan Haisco Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

To be enrolled in the study, subjects must meet the following criteria:
1.Male, aged 18 - 49 years (inclusive)
2.Be in general good health without clinically significant medical history, as determined by the investigator
3.American Society of Anesthesiologists Physical Status Classification of I or II
4.Body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
5.Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1
6.Normal or non-clinically significant findings on a physical examination, 12-lead ECG and vital signs (respiration rate between 12 and 20 breaths per minute, BP between 100-140/50-90 mmHg, heart rate between 45-99 beats per minute, temperature between 35.8 degrees and 37.5 degrees). Pulse oximetry values >95% on room air.
7.Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
8.Ability to provide written informed consent
9.Willing and able to follow study instructions and likely to complete all study requirements
10.Suitable venous and arterial access.

Exclusion Criteria

Subjects will be ineligible for entry into the study if any of the following apply:
1.History of allergy or sensitivity to: propofol, etomidate or components of HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine
2.History of clinically significant problems with anesthesia induction
3.Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening
4.History of excessive alcohol intake (more than 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months prior to screening
5.Intake of > 8 caffeine-containing drinks per day, on average, or approximately 800mg of caffenine daily on average; history of intolerance of abstinencce from caffeine for 3 days
6.Use of prescription or over the counter medications within 7 days of investigational product administration, with the exception of paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed the recommended daily dose), unless agreed as non-clinically relevant by the investigator and sponsor.
7.Standard donation of blood within 30 days of the study
8.Donation of plasma or participation in a plasmapheresis program within 7 days of investigational product administration
9.Receipt of any investigational study drug within 30 days prior to screening
10.Unable to fast for the 6 hours prior to investigational product administration
11.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
12.Anticipated need for surgery or hospitalization during the study
13.Craniofacial abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
14.History of seizures or epilepsy
15.History of ischaemic heart disease
16.History of brady- or tachy-dysrhythmias requiring medical care
17.History of asthma, with bronchospasm requiring treatment in the last 3 months
18.Any condition, which in the investigator’s opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject’s participation in the study
19.Receipt of HSK3486 less than 4 weeks prior to the start of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified