<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/NCT02189733</url>
  </required_header>
  <id_info>
    <org_study_id>ALX0681-C102</org_study_id>
    <secondary_id>2014-001294-13</secondary_id>
    <nct_id>NCT02189733</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.</brief_title>
  <official_title>A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ablynx, a Sanofi company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ablynx, a Sanofi company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the pharmacokinetic characteristics and&#xD;
      demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for&#xD;
      subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference&#xD;
      liquid formulation of caplacizumab.&#xD;
&#xD;
      The secondary objective of the study is to compare the safety and tolerability, and the&#xD;
      pharmacodynamic parameters of the new formulation with those of the reference formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">September 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: concentration of caplacizumab in plasma</measure>
    <time_frame>Day 1 (pre-dose) until Day 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics as measured by Ristocetin cofactor activity in plasma</measure>
    <time_frame>During screening until day 29 +/-1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability: safety markers</measure>
    <time_frame>From signing of informed consent form until day 43 +/- 2</time_frame>
    <description>Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics as measured by von Willebrand factor antigen in plasma</measure>
    <time_frame>During screening until Day 29 +/- 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics as measured by Factor VIII clotting activity in plasma</measure>
    <time_frame>During screening until day 29 +/- 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Caplacizumab - Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caplacizumab - Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Caplacizumab</intervention_name>
    <description>Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab</description>
    <arm_group_label>Caplacizumab - Treatment A</arm_group_label>
    <arm_group_label>Caplacizumab - Treatment B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male Caucasians aged 18 to 55 years, inclusive.&#xD;
&#xD;
          -  Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes&#xD;
             included.&#xD;
&#xD;
          -  Coagulation and bleeding diathesis variables (as defined in the protocol) within the&#xD;
             normal range at screening and on Day -1.&#xD;
&#xD;
          -  Others as defined in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of diseases in the kidneys and/or heart, lungs, liver, skin,&#xD;
             endocrine organs or other condition known to interfere with the absorption,&#xD;
             distribution, metabolism or excretion of drugs.&#xD;
&#xD;
          -  History of and/or any sign or symptom indicating current abnormal hemostasis or blood&#xD;
             dyscrasia.&#xD;
&#xD;
          -  Others as defined in the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Jean-Michel Paillarse, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ablynx, a Sanofi company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>November 13, 2014</last_update_submitted>
  <last_update_submitted_qc>November 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 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/NCT02189733
org study id: ALX0681-C102
secondary id: 2014-001294-13
nct id: NCT02189733
lead sponsor: 
has dmc: No
The primary objective of the study is to evaluate the pharmacokinetic characteristics and
      demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for
      subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference
      liquid formulation of caplacizumab.

      The secondary objective of the study is to compare the safety and tolerability, and the
      pharmacodynamic parameters of the new formulation with those of the reference formulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics: concentration of caplacizumab in plasma
time frame: Day 1 (pre-dose) until Day 7
measure: Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
time frame: During screening until day 29 +/-1
measure: Safety and Tolerability: safety markers
time frame: From signing of informed consent form until day 43 +/- 2
description: Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations
measure: Pharmacodynamics as measured by von Willebrand factor antigen in plasma
time frame: During screening until Day 29 +/- 1
measure: Pharmacodynamics as measured by Factor VIII clotting activity in plasma
time frame: During screening until day 29 +/- 1
arm group label: Caplacizumab - Treatment A
arm group type: Experimental
description: Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab
arm group label: Caplacizumab - Treatment B
arm group type: Experimental
description: Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab
intervention type: Biological
intervention name: Caplacizumab
description: Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
arm group label: Caplacizumab - Treatment A
arm group label: Caplacizumab - Treatment B
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Michel Paillarse, MD
role: Study Director
affiliation: Ablynx, a Sanofi company
facility: 
country: United Kingdom
responsible party type: Sponsor