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

NCT03773835 | Completed Phase 1

• 1 other identifier: HSK3486-101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Apnea

  No movement of chest wall and cessation of end-tidal carbon dioxide waveform \> 15 seconds.

  First dose of study drug on day 1

• Safety by measurement of Adverse Events

  First dose of study drug on day 1

Secondary Outcomes (9)

• Modified observer's assessment of alertness/sedation（MOAA/S）

  From first dose of study drug until fully alert on day 1

• Bispectral index （BIS）

  From first dose of study drug until fully alert on day 1

• Median effective dose (ED50)

  From first dose of study drug until fully alert on day 1

• Peak concentration (Cmax)

  From the start of administration to 48 hours after administration

• Time to plasma peak concentration(Tmax)

  From the start of administration to 48 hours after administration

Study Arms (1)

HSK3486

EXPERIMENTAL

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

Drug: HSK3486

Interventions

HSK3486 DRUG

Mmanual IV bolus injection completed in 1 minute.

HSK3486

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

MeSH Terms

Interventions

HSK3486

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 12, 2018
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 3, 2020

Record last verified: 2016-08