xml: <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/NCT06002555</url>
    </required_header>
    <id_info>
      <org_study_id>TA799-018</org_study_id>
      <nct_id>NCT06002555</nct_id>
    </id_info>
    <brief_title>Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation</brief_title>
    <official_title>A Randomized Open-label, Single Dose, 3-Period, 6-Sequence, Cross-Over Trial With Washout Periods of at Least 14 Days to Investigate the Relative Bioavailability of Apraglutide in Dual Chamber Syringes Versus the Reference Formulation in Vials Following Subcutaneous Administrations in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VectivBio AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VectivBio AG</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This trial compares the relative bioavailability of apraglutide in dual-chamber syringes&#xD;
        (DCS) versus the reference formulation apraglutide in vials.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, open-label, randomized, three-period, and six-sequence cross-over&#xD;
        trial with two washout periods of at least 14 days to compare the relative bioavailability of&#xD;
        apraglutide using DCS versus the reference formulation in vials, following SC administrations&#xD;
        in healthy male and female subjects.&#xD;
  &#xD;
        Following consent, subjects will undergo a Screening procedure to see if they are suitable to&#xD;
        be enrolled in the trial. Screening may be performed up to 28 days prior to the first&#xD;
        injection procedure. All eligible subjects will receive the following treatments in three&#xD;
        separate treatment periods:&#xD;
  &#xD;
          -  Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL&#xD;
  &#xD;
          -  Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a&#xD;
             concentration of 6.25 mg/mL&#xD;
  &#xD;
          -  Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of&#xD;
             the current formulation-reference There will be a 14-day washout period between the&#xD;
             first and second treatment periods and between the second and third treatment periods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 23, 2023</start_date>
    <completion_date type="Anticipated">September 23, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 23, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>0 to 312 hours post dose in each period</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma apraglutide primary PK parameter: AUCinf or AUClast</measure>
      <time_frame>0 to 312 hours post dose in each period</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of maximum plasma concentration (tmax)</measure>
      <time_frame>0 to 312 hours post dose in each period</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination rate constant (λz)</measure>
      <time_frame>0 to 312 hours post dose in each period</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal half-life (t½)</measure>
      <time_frame>0 to 312 hours post dose in each period</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence, nature and severity of adverse events (AE) with apraglutide</measure>
      <time_frame>Baseline to Day 79</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical chemistry</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>Clinical Chemistry panel of analytes will be examined for clinically significant changes.&#xD;
  Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematology</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>Hematology panel of analytes will be examined for clinically significant changes.&#xD;
  Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemostasis</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>Hemostasis INR will be examined for clinically significant changes.&#xD;
  INR levels will be listed by subject. Descriptive statistics will be used to assess any changes in hemostasis results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibodies (ADA) analysis</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>ADA will be will be examined for clinically significant changes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine analysis</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>Urine analysis panel of analytes will be examined for clinically significant changes.&#xD;
  Urine analysis data will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>ECG QT Interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>ECG PR interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>ECG QRS interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Baseline to Day 79</time_frame>
      <description>ECG rhythm</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>Single SC dose of 5 mg from DCS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Two concomitant single SC doses of 2.5 mg from DCS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Single SC dose of 5 mg from vial</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Apraglutide</intervention_name>
      <description>Peptide analogue of GLP-2</description>
      <arm_group_label>Single SC dose of 5 mg from DCS</arm_group_label>
      <arm_group_label>Single SC dose of 5 mg from vial</arm_group_label>
      <arm_group_label>Two concomitant single SC doses of 2.5 mg from DCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18 and 67 years inclusive&#xD;
  &#xD;
            -  Subjects willing and able to comply with the study procedures&#xD;
  &#xD;
            -  Subjects able to understand and willing to sign the informed consent&#xD;
  &#xD;
            -  Body mass index (BMI) of ≥18.0 to ≤35.0 kg/m2; and a total body weight of &gt;50 kg&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or&#xD;
               with vasectomized partner. Sterilized or infertile or postmenopausal females.&#xD;
  &#xD;
            -  Male subjects with a WOCBP partner using highly effective methods of contraception and&#xD;
               agreeing on no sperm donation during the trial and for 4 weeks after (EOT) visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of clinically significant gastrointestinal, bronchopulmonary, neurological,&#xD;
               cardiovascular, endocrine, or allergic disease&#xD;
  &#xD;
            -  Known hypersensitivity to the investigational medicinal products (IMP), any of their&#xD;
               excipients or drugs of the same class&#xD;
  &#xD;
            -  If capable of reproduction, unwilling to use an effective form of contraception&#xD;
  &#xD;
            -  If a WOCBP, a positive blood pregnancy test&#xD;
  &#xD;
            -  Breast-feeding women&#xD;
  &#xD;
            -  Positive urine/blood test for alcohol and drugs of abuse&#xD;
  &#xD;
            -  Use of prohibited medications or herbal remedies&#xD;
  &#xD;
            -  Known presence or history of intestinal polyps&#xD;
  &#xD;
            -  Known presence or history of any type of cancer&#xD;
  &#xD;
            -  Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas&#xD;
               infection, and increased blood amylase and lipase (&gt;2.0-5.0× upper limit of normal&#xD;
               range) at Screening or on Day -1 of each period&#xD;
  &#xD;
            -  Participation in an investigational drug or device study within 30 days prior to&#xD;
               screening&#xD;
  &#xD;
            -  Donation of blood over 500 mL within 3 months prior to screening&#xD;
  &#xD;
            -  Use of tobacco products (i.e., smokes more than 10 cigarettes per day or equivalent)&#xD;
  &#xD;
            -  Concomitant disease or condition that could interfere with, or for which the treatment&#xD;
               of might interfere with, the conduct of the study, or that would, in the opinion of&#xD;
               the Investigator, pose an unacceptable risk to the subject in this trial&#xD;
  &#xD;
            -  Any intercurrent clinically significant illness in the previous 28 days before Day 1&#xD;
               of this study&#xD;
  &#xD;
            -  Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo,&#xD;
               hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), hepatitis B core antigen&#xD;
               (anti-HBc) or hepatitis C virus (HCV)&#xD;
  &#xD;
            -  Unwillingness or inability to comply with the study protocol for any other reason&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>67 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bolognani</last_name>
      <role>Study Director</role>
      <affiliation>VectivBio AG</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lasiene</last_name>
      <phone>+41615513030</phone>
      <email>clinicaltrials@vectivbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>ICON Clinical Research Unit</name>
        <address>
          <city>Groningen</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Relative bioavailability</keyword>
    <keyword>Dual-chamber syringe</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002555
  org study id: TA799-018
  nct id: NCT06002555
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This trial compares the relative bioavailability of apraglutide in dual-chamber syringes
        (DCS) versus the reference formulation apraglutide in vials.
  This is a single-center, open-label, randomized, three-period, and six-sequence cross-over
        trial with two washout periods of at least 14 days to compare the relative bioavailability of
        apraglutide using DCS versus the reference formulation in vials, following SC administrations
        in healthy male and female subjects.
  
        Following consent, subjects will undergo a Screening procedure to see if they are suitable to
        be enrolled in the trial. Screening may be performed up to 28 days prior to the first
        injection procedure. All eligible subjects will receive the following treatments in three
        separate treatment periods:
  
          -  Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL
  
          -  Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a
             concentration of 6.25 mg/mL
  
          -  Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of
             the current formulation-reference There will be a 14-day washout period between the
             first and second treatment periods and between the second and third treatment periods.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)
  time frame: 0 to 312 hours post dose in each period
  measure: Plasma apraglutide primary PK parameter: AUCinf or AUClast
  time frame: 0 to 312 hours post dose in each period
  measure: Time of maximum plasma concentration (tmax)
  time frame: 0 to 312 hours post dose in each period
  measure: Terminal elimination rate constant (λz)
  time frame: 0 to 312 hours post dose in each period
  measure: Terminal half-life (t½)
  time frame: 0 to 312 hours post dose in each period
  measure: Incidence, nature and severity of adverse events (AE) with apraglutide
  time frame: Baseline to Day 79
  measure: Clinical chemistry
  time frame: Baseline to Day 79
  description: Clinical Chemistry panel of analytes will be examined for clinically significant changes.
  Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Hematology
  time frame: Baseline to Day 79
  description: Hematology panel of analytes will be examined for clinically significant changes.
  Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Hemostasis
  time frame: Baseline to Day 79
  description: Hemostasis INR will be examined for clinically significant changes.
  INR levels will be listed by subject. Descriptive statistics will be used to assess any changes in hemostasis results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Anti-drug antibodies (ADA) analysis
  time frame: Baseline to Day 79
  description: ADA will be will be examined for clinically significant changes
  measure: Urine analysis
  time frame: Baseline to Day 79
  description: Urine analysis panel of analytes will be examined for clinically significant changes.
  Urine analysis data will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Baseline to Day 79
  description: ECG QT Interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Baseline to Day 79
  description: ECG PR interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Baseline to Day 79
  description: ECG QRS interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Baseline to Day 79
  description: ECG rhythm
  arm group label: Single SC dose of 5 mg from DCS
  arm group type: Experimental
  arm group label: Two concomitant single SC doses of 2.5 mg from DCS
  arm group type: Experimental
  arm group label: Single SC dose of 5 mg from vial
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Apraglutide
  description: Peptide analogue of GLP-2
  arm group label: Single SC dose of 5 mg from DCS
  arm group label: Single SC dose of 5 mg from vial
  arm group label: Two concomitant single SC doses of 2.5 mg from DCS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 67 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bolognani
  role: Study Director
  affiliation: VectivBio AG
  last name: Lasiene
  phone: +41615513030
  email: clinicaltrials@vectivbio.com
  facility: 
  status: Recruiting
  country: Netherlands
  responsible party type: Sponsor