<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/NCT03803163</url>
  </required_header>
  <id_info>
    <org_study_id>TCP-PH-101</org_study_id>
    <nct_id>NCT03803163</nct_id>
  </id_info>
  <brief_title>A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers</brief_title>
  <official_title>A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of TransCon PEG Treprostinil Administered as a Subcutaneous Injection in Healthy Adult Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascendis Pharma A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascendis Pharma A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the maximum tolerated dose (MTD) and assess safety and tolerability of&#xD;
      escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection&#xD;
      to healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Discontinued early due to local tolerance expectations not being met.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>42 days</time_frame>
    <description>Safety and tolerability of single doses of TransCon Treprostinil treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration [Cmax] of TransCon Treprostinil</measure>
    <time_frame>42 days</time_frame>
    <description>Pharmacokinetic profile of single doses of TransCon Treprostinil</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>TransCon Treprostinil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TransCon Treprostinil</intervention_name>
    <arm_group_label>TransCon Treprostinil</arm_group_label>
    <other_name>ACP-009</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject gives voluntary written informed consent to participate in the study.&#xD;
&#xD;
          2. Subject is a healthy male between the ages of 18 and 50 years, inclusive, at&#xD;
             Screening.&#xD;
&#xD;
          3. Subjects must weigh between 60 and 120 kg, inclusive, with a BMI between 19.0-32.0&#xD;
             kg/m2, inclusive at Screening.&#xD;
&#xD;
          4. Subject has a medical history, physical examination, vital signs, ECG and clinical&#xD;
             laboratory results within normal limits or considered not clinically significant by&#xD;
             the Investigator at Screening.&#xD;
&#xD;
          5. Subject agrees to abstain from taking any prescription medication for 14 days prior to&#xD;
             check-in and to abstain from taking any non-prescription medications (except&#xD;
             multivitamins) or herbal supplements for 7 3 days prior to check-in Baseline until&#xD;
             discharge from the study (unless prescribed by the Investigator to treat an AE).&#xD;
&#xD;
          6. Subject agrees to abstain from consuming alcohol from three days prior to check-in and&#xD;
             until discharge from the study.&#xD;
&#xD;
          7. Subject agrees to refrain from strenuous exercise from check-in and until discharge&#xD;
             from the study.&#xD;
&#xD;
          8. Subject is able to communicate effectively with study personnel and be considered&#xD;
             reliable, willing and cooperative in terms of compliance with the protocol&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any clinically relevant abnormality identified during the screening&#xD;
             physical examination, 12-lead ECG, or laboratory examinations.&#xD;
&#xD;
          2. Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction,&#xD;
             or a clinically significant idiosyncratic reaction to any drug.&#xD;
&#xD;
          3. Subject has a clinically significant history of neurological, cardiovascular,&#xD;
             respiratory, endocrine, hematological, hepatic, renal, gastrointestinal,&#xD;
             genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric&#xD;
             disorder, or any other chronic disease, whether controlled by medication or not.&#xD;
&#xD;
          4. Subject has a history of postural hypotension, or unexplained syncope.&#xD;
&#xD;
          5. Subject has a blood pressure that is less than 90 mmHg systolic or 50 mmHg diastolic&#xD;
             at Screening or Baseline.&#xD;
&#xD;
          6. Subject has a pulse rate that is greater than 90 bpm after sitting at rest for at&#xD;
             least 5 minutes at Screening or Baseline.&#xD;
&#xD;
          7. Subject has a history of hypertension.&#xD;
&#xD;
          8. Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg&#xD;
             diastolic at Screening or Baseline&#xD;
&#xD;
          9. Subject has a predisposing condition that could interfere with the absorption,&#xD;
             distribution, metabolism, or excretion of drugs.&#xD;
&#xD;
         10. Subject has tested positive at the screening visit for HIV infection, HBsAg, or the&#xD;
             HCV antibody.&#xD;
&#xD;
         11. Subject currently uses tobacco or nicotine products or has a history of tobacco use&#xD;
             within six months prior to Baseline.&#xD;
&#xD;
         12. Subject has a history of alcohol abuse or a history of or current impairment of organ&#xD;
             function reasonably related to alcohol abuse.&#xD;
&#xD;
         13. Subject has a history of or current evidence of abuse of licit or illicit drugs,&#xD;
             including a positive urine screen for drugs of abuse at Screening or Baseline.&#xD;
&#xD;
         14. Subject has a history of abnormal bleeding tendencies.&#xD;
&#xD;
         15. Subject has donated blood or plasma or has lost a significant volume of blood (greater&#xD;
             than 450 mL) within four weeks prior to Baseline.&#xD;
&#xD;
         16. Subject has participated in any investigational drug study within 30 days prior to&#xD;
             their initial Screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Treprostinil</mesh_term>
  </intervention_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/NCT03803163
org study id: TCP-PH-101
nct id: NCT03803163
lead sponsor: 
has dmc: No
To determine the maximum tolerated dose (MTD) and assess safety and tolerability of
      escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection
      to healthy male volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 42 days
description: Safety and tolerability of single doses of TransCon Treprostinil treatment
measure: Maximum Plasma Concentration [Cmax] of TransCon Treprostinil
time frame: 42 days
description: Pharmacokinetic profile of single doses of TransCon Treprostinil
arm group label: TransCon Treprostinil
arm group type: Experimental
intervention type: Drug
intervention name: TransCon Treprostinil
arm group label: TransCon Treprostinil
other name: ACP-009
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Treprostinil