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/NCT06005402</url>
    </required_header>
    <id_info>
      <org_study_id>CSX-1004.101</org_study_id>
      <nct_id>NCT06005402</nct_id>
    </id_info>
    <brief_title>Safety, Tolerability, and Pharmacokinetics of CSX-1004</brief_title>
    <official_title>A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cessation Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dr. Vince Clinical Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cessation Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess&#xD;
        the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion&#xD;
        across a range of doses in healthy adult subjects. The study will have 3 phases: Screening,&#xD;
        Inpatient Treatment, and Outpatient Follow-up.&#xD;
  &#xD;
        The primary objective of the study is to determine the safety and tolerability of CSX-1004&#xD;
        Injection administered by intravenous (IV) infusion across a range of doses in healthy adult&#xD;
        subjects.&#xD;
  &#xD;
        The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004&#xD;
        Injection administered by IV infusion across a range of doses in healthy adult subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Single ascending dose study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation</measure>
      <time_frame>5 months</time_frame>
      <description>Incidence, intensity, and causality of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical laboratory assessments</measure>
      <time_frame>5 months</time_frame>
      <description>Hematology, biochemistry, and urinalysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vital signs</measure>
      <time_frame>5 months</time_frame>
      <description>Blood pressure and pulse rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>12-Lead electrocardiogram</measure>
      <time_frame>5 months</time_frame>
      <description>Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical examination</measure>
      <time_frame>5 months</time_frame>
      <description>Complete physical examination, assessing the subject's overall health and physical condition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Infusion site examination</measure>
      <time_frame>6 days</time_frame>
      <description>Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>4 months</time_frame>
      <description>Maximum serum concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUCinf</measure>
      <time_frame>4 months</time_frame>
      <description>Area under the curve from time zero extrapolated to infinity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUClast</measure>
      <time_frame>4 months</time_frame>
      <description>Area under the curve from time zero to the last measurable concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>4 months</time_frame>
      <description>Time to maximum serum concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2</measure>
      <time_frame>4 months</time_frame>
      <description>beta terminal elimination half-life</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Immunogenicity</measure>
      <time_frame>4 months</time_frame>
      <description>Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Opioid Overdose</condition>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>CSX-1004</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single doses of CSX-1004 Injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Sterile saline for injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>CSX-1004</intervention_name>
      <description>Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs</description>
      <arm_group_label>CSX-1004</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Sterile saline for injection</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Major Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male or female subjects, aged 18 to 50 years, inclusive,&#xD;
  &#xD;
            -  Minimum weight of 50.0 kg and maximum weight of 100.0 kg&#xD;
  &#xD;
            -  Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive&#xD;
  &#xD;
          Major Exclusion Criteria:&#xD;
  &#xD;
            -  Positive UDS for substances of abuse (including alcohol) at Screening or admission to&#xD;
               the Treatment Phase&#xD;
  &#xD;
            -  Current daily cigarette smoker within 3 months of Screening. Social smoking, as&#xD;
               defined by non-daily use of nicotine-containing products, is permitted.&#xD;
  &#xD;
            -  History or presence of any clinically significant cardiac, psychiatric, endocrine,&#xD;
               hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,&#xD;
               dermatologic, renal, or other major disease or illness at Screening, which in the&#xD;
               opinion of the Investigator, might jeopardize the safety of the subject or the&#xD;
               validity of the study results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Steven Hull, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dr. Vince Clinical Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brandi Eckard</last_name>
      <phone>913-333-3000</phone>
      <email>breckard@drvince.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lora Adriano</last_name>
      <phone>913-333-3000</phone>
      <email>ladriano@drvince.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dr. Vince Clinical Research</name>
        <address>
          <city>Overland Park</city>
          <state>Kansas</state>
          <zip>66212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brandi Eckard</last_name>
        <phone>913-333-3000</phone>
        <email>breckard@drvince.com</email>
      </contact>
      <contact_backup>
        <last_name>Lora Adriano</last_name>
        <phone>913-333-3000</phone>
        <email>ladriano@drvince.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Opioid-Related Disorders</mesh_term>
      <mesh_term>Opiate Overdose</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06005402
  org study id: CSX-1004.101
  nct id: NCT06005402
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess
        the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion
        across a range of doses in healthy adult subjects. The study will have 3 phases: Screening,
        Inpatient Treatment, and Outpatient Follow-up.
  
        The primary objective of the study is to determine the safety and tolerability of CSX-1004
        Injection administered by intravenous (IV) infusion across a range of doses in healthy adult
        subjects.
  
        The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004
        Injection administered by IV infusion across a range of doses in healthy adult subjects.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Single ascending dose study
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
  time frame: 5 months
  description: Incidence, intensity, and causality of adverse events
  measure: Clinical laboratory assessments
  time frame: 5 months
  description: Hematology, biochemistry, and urinalysis
  measure: Vital signs
  time frame: 5 months
  description: Blood pressure and pulse rate
  measure: 12-Lead electrocardiogram
  time frame: 5 months
  description: Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
  measure: Physical examination
  time frame: 5 months
  description: Complete physical examination, assessing the subject's overall health and physical condition
  measure: Infusion site examination
  time frame: 6 days
  description: Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
  measure: Cmax
  time frame: 4 months
  description: Maximum serum concentration
  measure: AUCinf
  time frame: 4 months
  description: Area under the curve from time zero extrapolated to infinity
  measure: AUClast
  time frame: 4 months
  description: Area under the curve from time zero to the last measurable concentration
  measure: Tmax
  time frame: 4 months
  description: Time to maximum serum concentration
  measure: t1/2
  time frame: 4 months
  description: beta terminal elimination half-life
  measure: Immunogenicity
  time frame: 4 months
  description: Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies
  arm group label: CSX-1004
  arm group type: Experimental
  description: Single doses of CSX-1004 Injection
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Sterile saline for injection
  intervention type: Biological
  intervention name: CSX-1004
  description: Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
  arm group label: CSX-1004
  intervention type: Biological
  intervention name: Placebo
  description: Sterile saline for injection
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Steven Hull, MD
  role: Principal Investigator
  affiliation: Dr. Vince Clinical Research
  last name: Brandi Eckard
  phone: 913-333-3000
  email: breckard@drvince.com
  last name: Lora Adriano
  phone: 913-333-3000
  email: ladriano@drvince.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Opioid-Related Disorders
  mesh term: Opiate Overdose
  sharing ipd: No