<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773835</url>
  </required_header>
  <id_info>
    <org_study_id>HSK3486-101</org_study_id>
    <nct_id>NCT03773835</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan Haisco Pharmaceutical Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haisco Pharmaceutical Group Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety,&#xD;
      tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable&#xD;
      emulsion in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea</measure>
    <time_frame>First dose of study drug on day 1</time_frame>
    <description>No movement of chest wall and cessation of end-tidal carbon dioxide waveform &gt; 15 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety by measurement of Adverse Events</measure>
    <time_frame>First dose of study drug on day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified observer's assessment of alertness/sedation（MOAA/S）</measure>
    <time_frame>From first dose of study drug until fully alert on day 1</time_frame>
    <description>Observe the change of modified observer's assessment of alert /sedation during the whole trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bispectral index （BIS）</measure>
    <time_frame>From first dose of study drug until fully alert on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median effective dose (ED50)</measure>
    <time_frame>From first dose of study drug until fully alert on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak concentration (Cmax)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to plasma peak concentration(Tmax)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half life (t1/2z) and mean residence time (MRT)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance (CL)</measure>
    <time_frame>From the start of administration to 48 hours after administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Anesthesia</condition>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>HSK3486</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg,</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HSK3486</intervention_name>
    <description>Mmanual IV bolus injection completed in 1 minute.</description>
    <arm_group_label>HSK3486</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males or females with full capacity for civil conduct, between 18 and 49 years&#xD;
             old (inclusive);&#xD;
&#xD;
          2. Body weight &gt; 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;&#xD;
&#xD;
          3. Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body&#xD;
             temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute;&#xD;
             SpO2 when inhaling &gt; 95%;&#xD;
&#xD;
          4. Normal physical examination, laboratory tests (blood routine, blood biochemistry, and&#xD;
             urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal&#xD;
             but without clinical significance (determined by investigator); no potential difficult&#xD;
             airway;&#xD;
&#xD;
          5. Subjects must understand the procedures and methods of this study, and be willing to&#xD;
             provide informed consent and to complete the trial in strict accordance with clinical&#xD;
             trial protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known sensitivity to propofol, excipient in propofol medium and long chain fat&#xD;
             emulsion injection, excipient in HSK3486 injectable emulsion;&#xD;
&#xD;
          2. contraindicated in general anesthesia;&#xD;
&#xD;
          3. Received any one of the following medications or treatments prior to&#xD;
             screening/enrollment:&#xD;
&#xD;
               1. History of medication abuse or any signs of chronic benzodiazepines use (such as&#xD;
                  insomnia, anxiety, spasms) within 3 months prior to screening, or a positive&#xD;
                  urine medication test (during screening or at baseline);&#xD;
&#xD;
               2. Participated in clinical trials involving any medications or medical devices&#xD;
                  within 3 months prior to screening, or participated in 3 or more drug clinical&#xD;
                  trials within the past year;&#xD;
&#xD;
          4. History or evidence of increased risk of sedation or anesthesia, such as&#xD;
             cardiovascular disease, respiratory disease, cerebrovascular disease,&#xD;
             gastrodintestinal disease and other system disease prior to the screening and/or&#xD;
             baseline period;&#xD;
&#xD;
          5. Laboratory results that meet any of the following during screening/enrollment:&#xD;
&#xD;
               1. Positive for HBsAg, HCV, or HIV;&#xD;
&#xD;
               2. Abnormal hepatic or renal function confirmed after re-examination;&#xD;
&#xD;
                    -  ALT or AST &gt; ULN;&#xD;
&#xD;
                    -  Creatinine &gt; ULN;&#xD;
&#xD;
          6. History of smoking for more than 3 weeks and/or respiratory irritation caused by&#xD;
             smoking within 3 months prior to screening;&#xD;
&#xD;
          7. History of alcohol abuse within 3 months prior to screening or a positive alcohol test&#xD;
             (baseline);&#xD;
&#xD;
          8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who&#xD;
             are unwilling to use contraception during the trial;&#xD;
&#xD;
          9. Subjects judged by the investigator to be unsuitable for participating in this trial&#xD;
             for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773835
org study id: HSK3486-101
nct id: NCT03773835
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea
time frame: First dose of study drug on day 1
description: No movement of chest wall and cessation of end-tidal carbon dioxide waveform > 15 seconds.
measure: Safety by measurement of Adverse Events
time frame: First dose of study drug on day 1
measure: Modified observer's assessment of alertness/sedation（MOAA/S）
time frame: From first dose of study drug until fully alert on day 1
description: Observe the change of modified observer's assessment of alert /sedation during the whole trial
measure: Bispectral index （BIS）
time frame: From first dose of study drug until fully alert on day 1
measure: Median effective dose (ED50)
time frame: From first dose of study drug until fully alert on day 1
measure: Peak concentration (Cmax)
time frame: From the start of administration to 48 hours after administration
measure: Time to plasma peak concentration(Tmax)
time frame: From the start of administration to 48 hours after administration
measure: Terminal elimination half life (t1/2z) and mean residence time (MRT)
time frame: From the start of administration to 48 hours after administration
measure: Mean residence time (MRT)
time frame: From the start of administration to 48 hours after administration
measure: Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)
time frame: From the start of administration to 48 hours after administration
measure: Total clearance (CL)
time frame: From the start of administration to 48 hours after administration
arm group label: HSK3486
arm group type: Experimental
description: 0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg,
intervention type: Drug
intervention name: HSK3486
description: Mmanual IV bolus injection completed in 1 minute.
arm group label: HSK3486
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor