<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/NCT03001544</url>
  </required_header>
  <id_info>
    <org_study_id>TS CP01-2015</org_study_id>
    <nct_id>NCT03001544</nct_id>
  </id_info>
  <brief_title>Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer</brief_title>
  <acronym>TS23Phase1a</acronym>
  <official_title>Phase 1 Single-ascending Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Anti-alpha2-antiplasmin (α2AP) Monoclonal Antibody TS23 in Healthy Human Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Translational Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Translational Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a&#xD;
      single intravenous dose of TS23 in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics&#xD;
      of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha&#xD;
      2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose&#xD;
      trial at one clinical center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and severity of adverse events post-dose</measure>
    <time_frame>10 weeks</time_frame>
    <description>To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coagulation (fibrinogen, PT, aPTT)</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-drug antibody</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alpha2-antiplasmin activity</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter, maximum concentration of TS23</measure>
    <time_frame>10 weeks</time_frame>
    <description>Pharmacokinetic parameter Cmax of TS23 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter, half-life of TS23</measure>
    <time_frame>10 weeks</time_frame>
    <description>Pharmacokinetic parameter, time required for TS23 concentrations to fall by half</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Thrombosis</condition>
  <condition>Cerebral Ischemia</condition>
  <condition>Venous Thrombosis</condition>
  <condition>Pulmonary Embolism</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Experimental Ascending Dose Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TS23</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TS23</intervention_name>
    <description>comparison of different doses</description>
    <arm_group_label>Experimental Ascending Dose Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Healthy males age 18 years to 60 years of age&#xD;
&#xD;
          -  Body mass index ≥ 20 and ≤ 33 kg/m squared&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies or hypersensitivities to blood products or derivatives or therapeutic&#xD;
             proteins or product excipients or components of CHO cells&#xD;
&#xD;
          -  Current alcohol or drug abuse or history of alcohol or drug abuse&#xD;
&#xD;
          -  Participation in any trial with an investigational drug within 90 days prior to dosing&#xD;
&#xD;
          -  Blood donation of more than 500 mL of blood within 90 days prior to dosing&#xD;
&#xD;
          -  Any history of a bleeding or thrombotic disorder&#xD;
&#xD;
          -  Any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or&#xD;
             immunologic disorder&#xD;
&#xD;
          -  Over-the-counter medications, dietary supplements and herbal products (except a daily&#xD;
             vitamin) within 14 days of drug administration or during the study&#xD;
&#xD;
          -  No prescription medication for at least 14 days or 5-half-lives, whichever is longer,&#xD;
             prior to study drug administration.&#xD;
&#xD;
          -  Use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory&#xD;
             medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and&#xD;
             during the study&#xD;
&#xD;
          -  Known hereditary fructosemia (due to sorbitol in the formulation)&#xD;
&#xD;
          -  Any previous or current monoclonal antibody therapy&#xD;
&#xD;
          -  History of trauma or surgery within the past 60 days or planned surgery within 30 days&#xD;
&#xD;
          -  Abnormal baseline laboratory values or any laboratory values deemed clinically&#xD;
             significant by the Investigator&#xD;
&#xD;
          -  Recent history of head trauma in last 30 days prior to receiving TS23&#xD;
&#xD;
          -  Unwillingness or inability to avoid contact sports or other activities with more than&#xD;
             a small risk of head or facial trauma within 30 days of receiving TS23&#xD;
&#xD;
          -  History of or risk of falls (e.g., due to dementia, frailty, etc.)&#xD;
&#xD;
          -  Sexually active subjects must agree to use a reliable method of birth control&#xD;
             (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving&#xD;
             TS23&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</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>Pulmonary Embolism</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03001544
org study id: TS CP01-2015
nct id: NCT03001544
lead sponsor: 
has dmc: No
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a
      single intravenous dose of TS23 in healthy adults.
This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics
      of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha
      2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose
      trial at one clinical center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number and severity of adverse events post-dose
time frame: 10 weeks
description: To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
measure: Coagulation (fibrinogen, PT, aPTT)
time frame: 10 weeks
measure: Anti-drug antibody
time frame: 16 weeks
measure: alpha2-antiplasmin activity
time frame: 10 weeks
measure: D-dimer
time frame: 10 weeks
measure: Pharmacokinetic parameter, maximum concentration of TS23
time frame: 10 weeks
description: Pharmacokinetic parameter Cmax of TS23 in plasma
measure: Pharmacokinetic parameter, half-life of TS23
time frame: 10 weeks
description: Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
arm group label: Experimental Ascending Dose Cohort
arm group type: Experimental
description: TS23
intervention type: Biological
intervention name: TS23
description: comparison of different doses
arm group label: Experimental Ascending Dose Cohort
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Myocardial Infarction
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Infarction
mesh term: Ischemia