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Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04197661
Collaborator
The First Hospital of Jilin University (Other)
32
Enrollment
1
Location
4
Arms
4.9
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Study Evaluating Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Healthy Elderly Subjects
Actual Study Start Date :
Dec 25, 2019
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
May 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Elderly groupⅠ

Elderly groupⅠ 65 years or older 0.2 mg/kg HSK3486

Drug: HSK3486
Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
Other Names:
  • HSK3486 0.2 mg/kg

    		•
    Active Comparator: Elderly group Ⅱ

    Elderly group Ⅱ 65 years or older 0.3 mg/kg HSK3486

    Drug: HSK3486
    Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
    Other Names:
  • HSK3486 0.3 mg/kg

    		•
    Active Comparator: Elderly group Ⅲ

    Elderly group Ⅲ 65 years or older 0.4 mg/kg HSK3486

    Drug: HSK3486
    Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
    Other Names:
  • HSK3486 0.4 mg/kg

    		•
    Active Comparator: Non-elderly group IV

    Non-elderly group IV 18 to 64 years 0.4 mg/kg HSK3486

    Drug: HSK3486
    Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
    Other Names:
  • HSK3486 0.4 mg/kg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak concentration (Cmax) [-30 minutes before administration until 24 hours post administration on day 1]

      Cmax（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.

    2. Area under the concentration-time curve（AUC） [-30 minutes before administration until 24 hours post administration on day 1]

      AUC（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.

    Secondary Outcome Measures

    1. MOAA/S(modified observer's assessment of alert /sedation) [-5 minutes before administration until 1 hours post administration on day 1]

      modified observer's assessment of alert /sedation

    2. Bispectral index(BIS) [-5 minutes before administration until 1 hours post administration on day 1]

      Bispectral index

    3. Tmax [-30 minutes before administration until 24 hours post administration on day 1]

      time to peak observed

    4. Total clearance [-30 minutes before administration until 24 hours post administration on day 1]

      Total clearance

    5. blood pressure（systolic, diastolic and mean arterial pressure） [from the screening to 2 days post-dose]

      safety endpoits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Sign the informed consent form and fully understand the content, procedure and possible adverse effects before the trial starts;

    2. Able to complete the study in compliance with the requirements of the clinical trial protocol;

    3. Subjects (including their partners) are willing to voluntarily adopt an effective measure of contraception starting from screening to 6 months after the last dose of the investigational drug. See the attachment for specific contraceptive measures;

    4. Males and females with full capacity for civil conduct, aged ≥ 18 years old (aged between 18 and 64 years old for the non-elderly group and ≥ 65 years old for the elderly group (inclusive));

    5. Females weighing ≥ 45 kg and males weighing ≥ 50 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 (BMI = Weight (kg)/height2(m2))(inclusive);

    6. For all subjects, the body temperature should be between 35.9-37.6 °C, respiratory rate between 12-20 breaths/min, and SpO2 when inhaling > 95%; in addition, for subjects in the non-elderly group, the blood pressure should be between 90-140/60-90 mmHg and heart rate between 60-99 bpm; for those in the elderly group, the blood pressure should be between 90-160/60-100 mmHg and heart rate between 50-100 bpm;

    Exclusion Criteria:

    1. Smoke more than 5 cigarettes per day on average within 3 months prior to screening;

    2. Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;

    3. Known sensitivity to HSK3486 excipients (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); or history of drug allergies (including other anesthetics), allergic diseases, or those with hyperactive immuneresponse(allergies to various drugs and foods);

    4. History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening;

    5. Acute diseases with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases and infections (such as respiratory or CNS infections);

    6. History or evidence of cardiovascular diseases prior to screening: Uncontrolled hypertension [SBP ≥ 170 mmHg and/or DBP ≥ 105 mmHg without antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥ 450 ms (Fridericia's correction formula);

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phase I Clinical Trial Laboratory, The First Hospital of Jilin University Chang chun Ji Lin China 130021

    Sponsors and Collaborators

    • Sichuan Haisco Pharmaceutical Group Co., Ltd
    • The First Hospital of Jilin University

    Investigators

    • Study Director: Yanhua Ding, PhD, Phase I Clinical Trial Laboratory，The First Hospital of Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sichuan Haisco Pharmaceutical Group Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT04197661
    Other Study ID Numbers:
    • HSK3486-108
    First Posted:
    Dec 13, 2019
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sichuan Haisco Pharmaceutical Group Co., Ltd
    Healthy Elderly Subjects

    Study Results

    No Results Posted as of Dec 17, 2020