- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029766
A Study Evaluating Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 Single Bolus Dose Followed With a 30 Minute Constant Infusion in Healthy Male Subjects
January 26, 2021 updated by: Sichuan Haisco Pharmaceutical Group Co., Ltd
A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 in Healthy Male Subjects.
This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion 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, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C (HCVAb) 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 electrocardiogram (ECG) and vital signs (respiration rate between 12 and 20 breaths per minute, blood pressure (BP) 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.);
- 7. Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Investigator decided that out-of-range values were 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:
- 1. 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;
- 2. History of clinically significant problems with general anesthesia;
- 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 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 contraceptive medications, paracetamol, oral non-steroidal antiinflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the Principal Investigator and Sponsor;
- 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 study drug 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-related gastric 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, put the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HSK3486
0.288 mg/kg bolus (1 min)+ 1 mg/kg/h constant infusion (30 min) or 0.540 mg/kg bolus (1 min)+ 2 mg/kg/h constant infusion (30 min)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety by measurement of Adverse Events
Time Frame: First dose of study drug on day 1
|
First dose of study drug on day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median effective dose (ED50)
Time Frame: From first dose of study drug until fully alert on day 1
|
From first dose of study drug until fully alert on day 1
|
|
Peak concentration (Cmax)
Time Frame: From the start of administration to 48 hours after administration
|
From the start of administration to 48 hours after administration
|
|
Time to plasma peak concentration(Tmax)
Time Frame: From the start of administration to 48 hours after administration
|
From the start of administration to 48 hours after administration
|
|
Terminal elimination half life (t1/2z) and mean residence time (MRT)
Time Frame: From the start of administration to 48 hours after administration
|
From the start of administration to 48 hours after administration
|
|
Mean residence time (MRT)
Time Frame: From the start of administration to 48 hours after administration
|
From the start of administration to 48 hours after administration
|
|
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
|
From the start of administration to 48 hours after administration
|
|
Total clearance (CL)
Time Frame: From the start of administration to 48 hours after administration
|
From the start of administration to 48 hours after administration
|
|
Modified observer's assessment of alertness/sedation(MOAA/S)
Time Frame: From first dose of study drug until fully alert on day 1
|
Observe the change of modified observer's assessment of alert /sedation during the whole trial
|
From first dose of study drug until fully alert on day 1
|
Bispectral index (BIS)
Time Frame: From first dose of study drug until fully alert on day 1
|
From first dose of study drug until fully alert on day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2015
Primary Completion (Actual)
December 14, 2015
Study Completion (Actual)
June 9, 2016
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 20, 2019
First Posted (Actual)
July 23, 2019
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- HSK3486Australia-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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