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

NCT ID: NCT03773835

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-08-31

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 healthy subjects.

Conditions

Anesthesia; Sedation

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSK3486

0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg,

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: DRUG

Mmanual IV bolus injection completed in 1 minute.

Interventions

HSK3486

Mmanual IV bolus injection completed in 1 minute.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HSK3486-101

Identifier Type: -

Identifier Source: org_study_id