A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.

Anesthesia Clinical Trial

Official title:

A Single-center, Open-label, Uncontrolled, and Dose-escalation Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773835
• Other study ID #: HSK3486-101
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Sichuan Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

1. Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);

2. Body weight > 45 kg, and body mass index (BMI) = 19 and =24 kg/m2;

3. Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling > 95%;

4. Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;

5. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria:

1. Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;

2. contraindicated in general anesthesia;

3. Received any one of the following medications or treatments prior to screening/enrollment:

1. History of medication abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine medication test (during screening or at baseline);

2. Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or participated in 3 or more drug clinical trials within the past year;

4. History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;

5. Laboratory results that meet any of the following during screening/enrollment:

1. Positive for HBsAg, HCV, or HIV;

2. Abnormal hepatic or renal function confirmed after re-examination;

• ALT or AST > ULN;

• Creatinine > ULN;

6. History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;

7. History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);

8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;

9. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.

Related Conditions & MeSH terms

• Anesthesia
• Sedation

Intervention

Drug:
• HSK3486
Mmanual IV bolus injection completed in 1 minute.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Haisco Pharmaceutical Group Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea	No movement of chest wall and cessation of end-tidal carbon dioxide waveform > 15 seconds.	First dose of study drug on day 1
Primary	Safety by measurement of Adverse Events		First dose of study drug on day 1
Secondary	Modified observer's assessment of alertness/sedation(MOAA/S)	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
Secondary	Bispectral index (BIS)		From first dose of study drug until fully alert on day 1
Secondary	Median effective dose (ED50)		From first dose of study drug until fully alert on day 1
Secondary	Peak concentration (Cmax)		From the start of administration to 48 hours after administration
Secondary	Time to plasma peak concentration(Tmax)		From the start of administration to 48 hours after administration
Secondary	Terminal elimination half life (t1/2z) and mean residence time (MRT)		From the start of administration to 48 hours after administration
Secondary	Mean residence time (MRT)		From the start of administration to 48 hours after administration
Secondary	Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)		From the start of administration to 48 hours after administration
Secondary	Total clearance (CL)		From the start of administration to 48 hours after administration