A Phase 1, placebo and positive-controlled, dose-escalation study to determine the safety, pharmacodynamics and pharmacokinetics of a single intravenous injection ofHSK3486 in healthy subjects.
- Conditions
- AnesthesiaAnaesthesiology - Anaesthetics
- Registration Number
- ACTRN12614000428662
- Lead Sponsor
- Sichuan Haisco Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 48
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
3.American Society of Anesthesiologists (ASA) 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, nicotine, alcohol, hepatitis B surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse and alcohol pre-dose on Day -1
6.Normal or non-clinically significant 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 degrees and 37.5 degrees and pulse oximetry values > 95% on room air)
7.Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal 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, components of Fresofol 1% MCT/LCT propofolFresenius MCT/LCT 1%, or HSK3486 (soybean oil, glycerol, egg lecithin, disodium edentate, sodium hydroxide), or plain lignocaine
2.History of clinically significant problems with general anesthesia
3.Urinary cotinine levels indicative of smoking, 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 four standard drinks daily, on average) or use of recreational drugs within the last 3 months
5.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-steroidalanti-inflammatory agents
6.Standard donation of blood within 30 days of the study
7.Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study
8.Receipt of any investigational drug study within 30 days prior to screening
9.Unable to fast for the 6 hours prior to Investigational Product administration
10.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
11.Anticipated need for surgery or hospitalization during the study
12.Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
13.History of posture-relatedgastric reflux more than twice weekly
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method