<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/NCT02217488</url>
  </required_header>
  <id_info>
    <org_study_id>DG3173-I-001</org_study_id>
    <nct_id>NCT02217488</nct_id>
  </id_info>
  <brief_title>Single Ascending Dose Tolerability Study of DG3173</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspireo Pharmaceuticals Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DeveloGen AG, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aspireo Pharmaceuticals Limited</source>
  <brief_summary>
    <textblock>
      This clinical trial investigated the safety, tolerability and pharmacokinetic profile of&#xD;
      DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1&#xD;
      study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via&#xD;
      single dose subcutaneous injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <primary_completion_date type="Actual">September 2008</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of serious adverse events or withdrawals due to adverse events</measure>
    <time_frame>One week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>DG3173</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ethnic origine: Caucasian&#xD;
&#xD;
          -  Weight: 55-95 kg&#xD;
&#xD;
          -  BMI: 19-29 kg/qm&#xD;
&#xD;
          -  Medical history without clinically relevant pathologies&#xD;
&#xD;
          -  Physical examination parameters and lung function without signs of clinically relevant&#xD;
             pathologies&#xD;
&#xD;
          -  Electrocardiogram recording without signs of clinically relevant pathology, in&#xD;
             particular QTc (Bazett) &lt;440ms&#xD;
&#xD;
          -  Values for hematology, biochemistry and for coagulation tests of blood and urine&#xD;
             within the normal range or showing no clinically relevant deviation as judged by the&#xD;
             medical investigator (in particular normal values for ALAT, ASAT, LDH, gamma-GT,&#xD;
             alkaline phosphatase, alpha-amylase and bilirubin)&#xD;
&#xD;
          -  Having given written informed consent before any study-related activities are carried&#xD;
             out&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of clinically relevant pathology or disease&#xD;
&#xD;
          -  Any history of moderate or severe hypertension, hypotension or orthostatic hypotension&#xD;
&#xD;
          -  Mental handicap&#xD;
&#xD;
          -  Legal incapacity&#xD;
&#xD;
          -  Any history of clinically important emotional and/or psychiatric illness or of any&#xD;
             clinically important neurological disorders and/or epilepsy&#xD;
&#xD;
          -  Chronic diarrhea or other chronic gastrointestinal disorders&#xD;
&#xD;
          -  Acute or chronic gastro-duodenal ulcers&#xD;
&#xD;
          -  Presence or history of endocrine disorders&#xD;
&#xD;
          -  Presence or history of gall stone disease, presence excluded by means of upper&#xD;
             abdominal ultrasound&#xD;
&#xD;
          -  Known hypersensitivity to the study drug or constituent of the study drug&#xD;
&#xD;
          -  History of any relevant allergy, especially drug and/or food allergies&#xD;
&#xD;
          -  Strict vegetarian&#xD;
&#xD;
          -  Regular treatment with medications during three months prior to randomization&#xD;
&#xD;
          -  Receipt of any prescription or non-prescription medication, including multi-vitamin&#xD;
             preparations within 14 days prior to drug administration and for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Use of St. John´s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours&#xD;
             prior to randomization&#xD;
&#xD;
          -  Participation in a clinical study within 30 days prior to randomization&#xD;
&#xD;
          -  Donation of blood within 60 days prior to randomization&#xD;
&#xD;
          -  History of use of tobacco or nicotine-containing products within the past three months&#xD;
&#xD;
          -  Any history of alcohol abuse or drug addiction&#xD;
&#xD;
          -  Positive results at screen for drugs of abuse (cocaine, amphetamine/methamphetamine,&#xD;
             tetrahydrocannbinol, opiates) or alcohol (breath test) at screening or on admission&#xD;
&#xD;
          -  Positive screen results for HBsAg, anti-HCV, or anti-HIV1&amp;2&#xD;
&#xD;
          -  Consumption of abnormal quantities of coffee or tea (i.e. more than 5 cups per day [1&#xD;
             cup = 150 ml]&#xD;
&#xD;
          -  Any disease which in the Investigator´s opinion would exclude the subject from the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02217488
org study id: DG3173-I-001
nct id: NCT02217488
lead sponsor: 
collaborator: 
This clinical trial investigated the safety, tolerability and pharmacokinetic profile of
      DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1
      study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via
      single dose subcutaneous injection.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of serious adverse events or withdrawals due to adverse events
time frame: One week
arm group label: DG3173
arm group type: Experimental
arm group label: Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: DG3173
arm group label: DG3173
intervention type: Drug
intervention name: Placebo
arm group label: Vehicle
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor