Status:
COMPLETED
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Conditions:
Anesthesia
Sedation
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief 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 hea...
Eligibility Criteria
Inclusion
- Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);
- Body weight \> 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;
- 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%;
- 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;
- 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
- Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;
- contraindicated in general anesthesia;
- Received any one of the following medications or treatments prior to screening/enrollment:
- 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);
- 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;
- 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;
- Laboratory results that meet any of the following during screening/enrollment:
- Positive for HBsAg, HCV, or HIV;
- Abnormal hepatic or renal function confirmed after re-examination;
- ALT or AST \> ULN;
- Creatinine \> ULN;
- History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;
- History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03773835
Start Date
May 1 2016
End Date
August 1 2016
Last Update
March 3 2020
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