<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/NCT04419688</url>
  </required_header>
  <id_info>
    <org_study_id>STT-01</org_study_id>
    <nct_id>NCT04419688</nct_id>
  </id_info>
  <brief_title>A First in Human Study of STT-5058, an Antibody That Binds ApoC3</brief_title>
  <official_title>A Double-blind, Randomised, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple-ascending Doses of Intravenously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Single-ascending and Multiple Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Patient Volunteers With Hypertriglyceridemia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Staten Biotechnology BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Staten Biotechnology BV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and&#xD;
      multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in&#xD;
      otherwise healthy volunteers with elevated triglyceride levels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of&#xD;
      STT-5058 in otherwise healthy volunteers with TRGs &gt;150mg/dL. Part B is up to 4 multiple&#xD;
      ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs&#xD;
      &gt;150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort&#xD;
      of patient volunteers with TRG &gt;200mg/dL who will receive 3 doses at 2 week intervals of&#xD;
      STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058.&#xD;
      Part E will recruit a single cohort of otherwise healthy volunteers with TRG &gt; 150mg/dL to&#xD;
      receive 4 doses subcutaneously of STT-5058 over 4 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment failure&#xD;
  </why_stopped>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">December 23, 2022</completion_date>
  <primary_completion_date type="Actual">December 23, 2022</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>10 weeks</time_frame>
    <description>incidence and severity of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC</measure>
    <time_frame>10-14 weeks</time_frame>
    <description>Area under the PK curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>24 hours</time_frame>
    <description>Maximum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life</measure>
    <time_frame>10-14 weeks</time_frame>
    <description>time to reduction in plasma levels by 50%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>STT-5058</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STT-5058</intervention_name>
    <description>Monoclonal Antibody STT-5058</description>
    <arm_group_label>STT-5058</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo to STT-5058</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  in good health&#xD;
&#xD;
          -  Able to comprehend and willing to sign an ICF and to abide by the study restrictions.&#xD;
&#xD;
          -  Females will not be pregnant or lactating, and females of childbearing potential and&#xD;
             males will agree to use contraception Parts A, B and D&#xD;
&#xD;
          -  BMI between 18 and 35 kg/m2 inclusive&#xD;
&#xD;
          -  Fasting Triglycerides between 150 and 400mg/dL inclusive Part C&#xD;
&#xD;
          -  Fasting Triglycerides between 200 and 400 mg/dL inclusive&#xD;
&#xD;
          -  Fasting LDL-C between 70 and 160 mg/dL inclusive&#xD;
&#xD;
          -  BMI between 18 and 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant history or clinical manifestation of metabolic, allergic, dermatological,&#xD;
             hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal,&#xD;
             neurological, respiratory, endocrine, or psychiatric disorder, as determined by the&#xD;
             Investigator&#xD;
&#xD;
          -  Confirmed (eg, 2 consecutive measurements) systolic blood pressure &gt;150 or &lt;90 mmHg,&#xD;
             diastolic blood pressure &gt;90 or &lt;50 mmHg, and heart rate &gt;90 or &lt;40 beats per minute&#xD;
             at Screening, Check-in, or prior to dosing on Day 1.&#xD;
&#xD;
          -  History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.&#xD;
&#xD;
          -  Participation in a clinical study involving administration of an investigational drug&#xD;
             (new chemical entity) in the past 90 days or 5 half-lives (if known), whichever is&#xD;
             longer, prior to dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Covance Leeds Clinical Research Unit</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertriglyceridemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04419688
org study id: STT-01
nct id: NCT04419688
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and
      multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in
      otherwise healthy volunteers with elevated triglyceride levels
The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of
      STT-5058 in otherwise healthy volunteers with TRGs >150mg/dL. Part B is up to 4 multiple
      ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs
      >150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort
      of patient volunteers with TRG >200mg/dL who will receive 3 doses at 2 week intervals of
      STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058.
      Part E will recruit a single cohort of otherwise healthy volunteers with TRG > 150mg/dL to
      receive 4 doses subcutaneously of STT-5058 over 4 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety and tolerability
time frame: 10 weeks
description: incidence and severity of adverse events
measure: AUC
time frame: 10-14 weeks
description: Area under the PK curve
measure: Cmax
time frame: 24 hours
description: Maximum concentration
measure: Half life
time frame: 10-14 weeks
description: time to reduction in plasma levels by 50%
arm group label: STT-5058
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: STT-5058
description: Monoclonal Antibody STT-5058
arm group label: STT-5058
intervention type: Drug
intervention name: Placebo
description: Matching placebo to STT-5058
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypertriglyceridemia
sharing ipd: No