<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/NCT04475198</url>
  </required_header>
  <id_info>
    <org_study_id>ST-2427-CS-001</org_study_id>
    <secondary_id>1UG3DA049599</secondary_id>
    <nct_id>NCT04475198</nct_id>
  </id_info>
  <brief_title>Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SiteOne Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>SiteOne Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, double-blind, placebo controlled, study will be conducted to evaluate the&#xD;
      safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive&#xD;
      a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design.&#xD;
&#xD;
      A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of&#xD;
      ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized, double-blind, placebo-controlled study in healthy adult males&#xD;
      and females of non-child-bearing potential to evaluate the safety, tolerability, and&#xD;
      pharmacokinetics (PK) of ST-2427. This trial will include careful assessments of treatment&#xD;
      effects on vital signs including cardiac and respiratory function and body temperature over a&#xD;
      range of doses of ST-2427, administered as single doses. SiteOne Therapeutics, Inc. plans to&#xD;
      use the safety, tolerability, and PK findings from this study to inform the doses and study&#xD;
      design for Phase 2 clinical studies in subjects with acute post-operative pain.&#xD;
&#xD;
      Approximately 30 subjects, 6 subjects into each of 5 cohorts, will be enrolled in this study&#xD;
      at a single clinical site.&#xD;
&#xD;
      Subjects will be randomized 4:2 to receive a single dose of ST-2427 or placebo in a Single&#xD;
      Ascending Dose (SAD) design. The Study will evaluate 5 dose strengths of ST-2427, one dose&#xD;
      level in each of 5 cohorts of subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    strategic decision&#xD;
  </why_stopped>
  <start_date type="Actual">March 4, 2021</start_date>
  <completion_date type="Actual">August 18, 2021</completion_date>
  <primary_completion_date type="Actual">August 18, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events</measure>
    <time_frame>Day 1 through Day 8</time_frame>
    <description>For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events Assessed by Blood Pressure</measure>
    <time_frame>Day 1 through Day 8</time_frame>
    <description>Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events Assessed by ECG</measure>
    <time_frame>Day 1 through Day 8</time_frame>
    <description>Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments</measure>
    <time_frame>Day 1 through Day 8</time_frame>
    <description>Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events Assessed by Body Weight</measure>
    <time_frame>Day 1 through Day 8</time_frame>
    <description>Body weight (kg) will be assessed for changes relative to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax</measure>
    <time_frame>0-48 hours</time_frame>
    <description>PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</measure>
    <time_frame>0-9 hours</time_frame>
    <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</measure>
    <time_frame>0-25 hours</time_frame>
    <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Acute, Post-operative Pain</condition>
  <arm_group>
    <arm_group_label>Single Ascending Dose: Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (ST-2427 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose: Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose: Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose: Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose: Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>33 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ST-2427</intervention_name>
    <description>Investigational drug</description>
    <arm_group_label>Single Ascending Dose: Cohort 1</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 2</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 3</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 4</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>5% Dextrose Injection</description>
    <arm_group_label>Single Ascending Dose: Cohort 1</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 2</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 3</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 4</arm_group_label>
    <arm_group_label>Single Ascending Dose: Cohort 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only subjects who meet the following criteria will be eligible for inclusion:&#xD;
&#xD;
               1. Healthy adult males and/or females (of non-childbearing potential), 18 to 55&#xD;
                  years of age (inclusive) at the time of screening;&#xD;
&#xD;
               2. Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at&#xD;
                  least 50.0 kg at Screening);&#xD;
&#xD;
               3. Medically healthy without clinically significant abnormalities at the screening&#xD;
                  visit, including physical examination and vital signs within the following&#xD;
                  ranges: heart rate 50 to 100 bpm, systolic blood pressure 100 to 149 mmHg;&#xD;
                  diastolic 70 to 94 mmHg;&#xD;
&#xD;
               4. The mean QTcF interval duration ≤450 msec for males and ≤470 msec for females&#xD;
                  measured from the triplicate ECGs taken at least 1 minute apart with QT wave&#xD;
                  corrected for heart rate (HR) using Fredericia's method&#xD;
&#xD;
               5. Hemoglobin/hematocrit, white blood cell (WBC) count, and platelet count equal to&#xD;
                  or greater than the lower limit of normal range of the reference laboratory (may&#xD;
                  be confirmed upon repeat testing without Sponsor approval);&#xD;
&#xD;
               6. Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT) and&#xD;
                  aspartate aminotransferase (AST) equal to or less than the upper limit of normal&#xD;
                  for the reference laboratory (may be confirmed upon repeat testing); results of&#xD;
                  all other clinical chemistry and urine analytes without any clinically&#xD;
                  significant abnormality;&#xD;
&#xD;
               7. Non-smokers (including tobacco, e-cigarettes or marijuana), and no use of any&#xD;
                  tobacco product for at least 1 month prior to admission in the study;&#xD;
&#xD;
               8. Willing and able to provide written informed consent;&#xD;
&#xD;
               9. Willing and able to comply with all study assessments and adhere to the protocol&#xD;
                  schedule;&#xD;
&#xD;
              10. Have suitable venous access for blood sampling, as determined by an Investigator&#xD;
                  at screening;&#xD;
&#xD;
              11. If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated&#xD;
                  by follicle stimulating hormone (&gt;40 mIU/mL), or surgically sterilized by tubal&#xD;
                  ligation or hysterectomy). Site personnel's review of the subject's medical&#xD;
                  records, medical examination, or medical history interview is acceptable evidence&#xD;
                  of female sterilization, verbal confirmation is adequate;&#xD;
&#xD;
              12. If male, willing not to donate sperm from the time of first study drug&#xD;
                  administration until 90 days after the final administration of study drug. If&#xD;
                  male and not intending to engage in sexual intercourse over the duration of the&#xD;
                  study, willing to agree to abstinence at screening. If male and engaging in&#xD;
                  sexual intercourse, willing to use a double barrier method of contraception&#xD;
                  (condom and spermicide). The latter criterion applies to all males (and/or female&#xD;
                  partners) including males who are surgically sterile and must be followed from&#xD;
                  the time of first study drug administration until 90 days after the final&#xD;
                  administration of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
               1. History or presence of significant cardiovascular (including arrhythmia and&#xD;
                  ventricular tachyphylaxis), pulmonary, hepatic, renal, hematological,&#xD;
                  gastrointestinal, endocrine, immunologic, dermatologic or neurological disease,&#xD;
                  including any acute illness or surgery within the past 3 months determined by an&#xD;
                  Investigator to be clinically relevant;&#xD;
&#xD;
               2. Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT) and&#xD;
                  aspartate aminotransferase (AST) equal to 1.5 x upper limit of normal for the&#xD;
                  reference laboratory (may be confirmed upon repeat testing);&#xD;
&#xD;
               3. History of orthostatic reactions&#xD;
&#xD;
               4. Orthostatic reaction at screening defined as drop in systolic blood pressure by&#xD;
                  ≥20 mmHg or drop in systolic blood pressure to &lt;90 mmHg on standing for 3 minutes&#xD;
                  from the supine position.&#xD;
&#xD;
               5. History of seizure disorders, except for non-complex febrile seizures in&#xD;
                  childhood with absence of non-febrile seizures in parents and siblings.;&#xD;
&#xD;
               6. Positive urine drug/alcohol testing at Screening or Day -2;&#xD;
&#xD;
               7. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen&#xD;
                  (HBsAg) or Hepatitis C Antibody (HCVAb);&#xD;
&#xD;
               8. Positive test results for COVID-19 (PCR or Antibodies)&#xD;
&#xD;
               9. History of substance abuse or alcohol abuse (defined as greater than 2 standard&#xD;
                  drinks per day) within the previous 2 years;&#xD;
&#xD;
              10. Use of any prescription medication or any over-the-counter medication, including&#xD;
                  herbal products and vitamins within 14 days or 5 half-lives (whichever is longer)&#xD;
                  prior to randomization;&#xD;
&#xD;
              11. Documented hypersensitivity reaction or anaphylaxis to any medication;&#xD;
&#xD;
              12. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days&#xD;
                  prior to screening, or receipt of a blood transfusion within 1 year of screening;&#xD;
&#xD;
              13. Dosed in another investigational clinical trial within 30 days prior to&#xD;
                  Screening;&#xD;
&#xD;
              14. Any condition or prior therapy, e.g. seizures, or head trauma, that may lead to&#xD;
                  CNS effects during the study;&#xD;
&#xD;
              15. Documented or self-reported history of orthostatic hypotension or symptoms of&#xD;
                  hypotension such as dizziness, syncope or blurred vision upon standing;&#xD;
&#xD;
              16. Any condition which is associated with increased brain permeability, e.g.&#xD;
                  cerebral ischemia, brain trauma, multiple sclerosis, brain tumors, brain&#xD;
                  infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Jerling, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Unaffliated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Altasciences</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <results_first_submitted>June 16, 2023</results_first_submitted>
  <results_first_submitted_qc>July 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2023</results_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04475198/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Ascending Dose: Cohort 1</title>
          <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="P2">
          <title>Single Ascending Dose: Cohort 2</title>
          <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="P3">
          <title>Single Ascending Dose: Cohort 3</title>
          <description>15 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="P4">
          <title>Single Ascending Dose: Cohort 4</title>
          <description>22 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="P5">
          <title>Pooled Placebo</title>
          <description>placebo (n=2 per cohort) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Ascending Dose: Cohort 1</title>
          <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="B2">
          <title>Single Ascending Dose: Cohort 2</title>
          <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="B3">
          <title>Single Ascending Dose: Cohort 3</title>
          <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="B4">
          <title>Single Ascending Dose: Cohort 4</title>
          <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="B5">
          <title>Pooled Placebo</title>
          <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.0" spread="6.73"/>
                    <measurement group_id="B2" value="49.5" spread="3.42"/>
                    <measurement group_id="B3" value="40.0" spread="9.93"/>
                    <measurement group_id="B4" value="32.5" spread="13.03"/>
                    <measurement group_id="B5" value="43.4" spread="11.13"/>
                    <measurement group_id="B6" value="41.5" spread="10.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events</title>
        <description>For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.</description>
        <time_frame>Day 1 through Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O5">
            <title>Pooled Placebo</title>
            <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events</title>
          <description>For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events Assessed by Blood Pressure</title>
        <description>Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).</description>
        <time_frame>Day 1 through Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O5">
            <title>Pooled Placebo</title>
            <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Assessed by Blood Pressure</title>
          <description>Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events Assessed by ECG</title>
        <description>Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.</description>
        <time_frame>Day 1 through Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O5">
            <title>Pooled Placebo</title>
            <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Assessed by ECG</title>
          <description>Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments</title>
        <description>Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.</description>
        <time_frame>Day 1 through Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O5">
            <title>Pooled Placebo</title>
            <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments</title>
          <description>Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events Assessed by Body Weight</title>
        <description>Body weight (kg) will be assessed for changes relative to baseline.</description>
        <time_frame>Day 1 through Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O5">
            <title>Pooled Placebo</title>
            <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Assessed by Body Weight</title>
          <description>Body weight (kg) will be assessed for changes relative to baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax</title>
        <description>PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
        <time_frame>0-48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax</title>
          <description>PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206" spread="26.6"/>
                    <measurement group_id="O2" value="364" spread="51.0"/>
                    <measurement group_id="O3" value="551" spread="131"/>
                    <measurement group_id="O4" value="860" spread="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</title>
        <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
        <time_frame>0-9 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</title>
          <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="706" spread="111"/>
                    <measurement group_id="O2" value="1257" spread="74.2"/>
                    <measurement group_id="O3" value="1990" spread="132"/>
                    <measurement group_id="O4" value="2910" spread="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</title>
        <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
        <time_frame>0-25 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Ascending Dose: Cohort 1</title>
            <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O2">
            <title>Single Ascending Dose: Cohort 2</title>
            <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O3">
            <title>Single Ascending Dose: Cohort 3</title>
            <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
          <group group_id="O4">
            <title>Single Ascending Dose: Cohort 4</title>
            <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve</title>
          <description>PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.</description>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1044" spread="141"/>
                    <measurement group_id="O2" value="1864" spread="80.0"/>
                    <measurement group_id="O3" value="3003" spread="126"/>
                    <measurement group_id="O4" value="4312" spread="660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 through Day 8</time_frame>
      <desc>Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.</desc>
      <group_list>
        <group group_id="E1">
          <title>Single Ascending Dose: Cohort 1</title>
          <description>5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="E2">
          <title>Single Ascending Dose: Cohort 2</title>
          <description>10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="E3">
          <title>Single Ascending Dose: Cohort 3</title>
          <description>15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="E4">
          <title>Single Ascending Dose: Cohort 4</title>
          <description>22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.&#xD;
ST-2427: Investigational drug</description>
        </group>
        <group group_id="E5">
          <title>Pooled Placebo</title>
          <description>Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.&#xD;
Placebo: 5% Dextrose Injection</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Mulcahy</name_or_title>
      <organization>SiteOne Therapeutics</organization>
      <phone>+1 (650) 392-0419</phone>
      <email>john.mulcahy@site1therapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04475198
org study id: ST-2427-CS-001
secondary id: 1UG3DA049599
nct id: NCT04475198
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the
      safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive
      a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design.

      A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of
      ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
This is a Phase 1, randomized, double-blind, placebo-controlled study in healthy adult males
      and females of non-child-bearing potential to evaluate the safety, tolerability, and
      pharmacokinetics (PK) of ST-2427. This trial will include careful assessments of treatment
      effects on vital signs including cardiac and respiratory function and body temperature over a
      range of doses of ST-2427, administered as single doses. SiteOne Therapeutics, Inc. plans to
      use the safety, tolerability, and PK findings from this study to inform the doses and study
      design for Phase 2 clinical studies in subjects with acute post-operative pain.

      Approximately 30 subjects, 6 subjects into each of 5 cohorts, will be enrolled in this study
      at a single clinical site.

      Subjects will be randomized 4:2 to receive a single dose of ST-2427 or placebo in a Single
      Ascending Dose (SAD) design. The Study will evaluate 5 dose strengths of ST-2427, one dose
      level in each of 5 cohorts of subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-blind
measure: Number of Participants With Treatment-emergent Adverse Events
time frame: Day 1 through Day 8
description: For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
measure: Number of Participants With Adverse Events Assessed by Blood Pressure
time frame: Day 1 through Day 8
description: Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).
measure: Number of Participants With Adverse Events Assessed by ECG
time frame: Day 1 through Day 8
description: Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.
measure: Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments
time frame: Day 1 through Day 8
description: Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
measure: Number of Participants With Adverse Events Assessed by Body Weight
time frame: Day 1 through Day 8
description: Body weight (kg) will be assessed for changes relative to baseline.
measure: Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax
time frame: 0-48 hours
description: PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
measure: Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
time frame: 0-9 hours
description: PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
measure: Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
time frame: 0-25 hours
description: PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
arm group label: Single Ascending Dose: Cohort 1
arm group type: Experimental
description: 5 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (ST-2427 n=1, placebo n=1) before remainder of cohort.
arm group label: Single Ascending Dose: Cohort 2
arm group type: Experimental
description: 10 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
arm group label: Single Ascending Dose: Cohort 3
arm group type: Experimental
description: 15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
arm group label: Single Ascending Dose: Cohort 4
arm group type: Experimental
description: 22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
arm group label: Single Ascending Dose: Cohort 5
arm group type: Experimental
description: 33 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
intervention type: Drug
intervention name: ST-2427
description: Investigational drug
arm group label: Single Ascending Dose: Cohort 1
arm group label: Single Ascending Dose: Cohort 2
arm group label: Single Ascending Dose: Cohort 3
arm group label: Single Ascending Dose: Cohort 4
arm group label: Single Ascending Dose: Cohort 5
intervention type: Drug
intervention name: Placebo
description: 5% Dextrose Injection
arm group label: Single Ascending Dose: Cohort 1
arm group label: Single Ascending Dose: Cohort 2
arm group label: Single Ascending Dose: Cohort 3
arm group label: Single Ascending Dose: Cohort 4
arm group label: Single Ascending Dose: Cohort 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markus Jerling, MD, PhD
role: Study Director
affiliation: Unaffliated
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 