<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/NCT04482569</url>
  </required_header>
  <id_info>
    <org_study_id>XNW4107-001</org_study_id>
    <nct_id>NCT04482569</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin</brief_title>
  <official_title>A Phase 1, Randomized, Double Blind, Placebo Controlled Sequential Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XNW4107 for Injection, and Multiple Doses of XNW4107 for Injection in Combination With Imipenem/Cilastatin for Injection in Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evopoint Biosciences Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Evopoint Biosciences 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 3-part, first-in-human study to evaluate the safety, tolerability and&#xD;
      pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy&#xD;
      male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects&#xD;
      will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with&#xD;
      imipenem/cilastatin for 14 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as assessed by number of participants experiencing adverse events</measure>
    <time_frame>Change from baseline up to day 43 post-intervention</time_frame>
    <description>Number of participants who experience adverse events in different grades, as defined by Common Terminology for Adverse Events (CTCAE) v5.0</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Bacterial Infections</condition>
  <arm_group>
    <arm_group_label>Single Ascending Dose Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six XNW4107 doses ( 50-1250 mg ), each administered as a single dose with 60-minute IV infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three XNW4107 doses (167-500 mg), each administered as 60-minute IV infusion every 6 hours for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Dose Study of XNW4107 +Imipenem/Cilastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 mg XNW4107 co-administered with imipenem/cilastatin as 60-minute IV infusion every 6 hours for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XNW4107</intervention_name>
    <description>Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin</description>
    <arm_group_label>Multiple Ascending Dose Study</arm_group_label>
    <arm_group_label>Multiple Dose Study of XNW4107 +Imipenem/Cilastatin</arm_group_label>
    <arm_group_label>Single Ascending Dose Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male adults aged 18-65 years&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18.5 - 32.0, inclusive.&#xD;
&#xD;
          -  In good general health, as determined by the Investigator, based on medical history,&#xD;
             physical examination, 12 lead electrocardiogram (ECG), vital sign (VS) measurements,&#xD;
             and laboratory test results.&#xD;
&#xD;
          -  Normal blood pressure (BP), defined as: systolic BP (SBP) ≥90 mmHg and ≤140 mmHg; and&#xD;
             diastolic BP (DBP) &lt;90 mmHg at the time of Screening&#xD;
&#xD;
          -  Male subjects with female partners of reproductive potential must agree to practice&#xD;
             abstinence or to use a condom (male subject) in addition to an acceptable method&#xD;
             (female partner) of contraception for the duration of the study and for at least 90&#xD;
             days post last dose.&#xD;
&#xD;
          -  Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C&#xD;
             antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E&#xD;
             immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody&#xD;
             chemiluminescent immunoassay (TP IA).&#xD;
&#xD;
          -  Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C&#xD;
             antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E&#xD;
             immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody&#xD;
             chemiluminescent immunoassay (TP IA).&#xD;
&#xD;
          -  Non smoker (with no use of other tobacco or nicotine containing products, in any&#xD;
             form), as documented by history (no nicotine within 3 months prior to Screening)&#xD;
&#xD;
          -  Negative results for drugs of abuse, alcohol, and cotinine at Screening and Admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant psychiatric disorder within the past 5 years.&#xD;
&#xD;
          -  History of stroke, chronic seizures, or other major neurological disorder.&#xD;
&#xD;
          -  History or evidence of drug/alcohol abuse within 1 year prior to Screening.&#xD;
&#xD;
          -  History of clinically significant endocrine, neurological, gastrointestinal,&#xD;
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or&#xD;
             genitourinary abnormalities or disease.&#xD;
&#xD;
          -  History of cancer (malignancy).&#xD;
&#xD;
          -  History of any illness that, in the opinion of the study investigator, may confound&#xD;
             the results of the study or pose additional risk to the subject if he participates in&#xD;
             the study.&#xD;
&#xD;
          -  Administration of another investigational medication within 30 days (or 5 half lives,&#xD;
             whichever is longer) prior to study drug administration.&#xD;
&#xD;
          -  Participation in an investigational device study within 30 days prior to study drug&#xD;
             administration.&#xD;
&#xD;
          -  Excessive consumption of alcohol, defined as &gt;3 alcoholic beverages per day (10 ounces&#xD;
             of beer [284 mL], 4 ounces of wine [125 mL], or 1 ounce of distilled spirits [25 mL]&#xD;
             is approximately equivalent to 1 alcoholic beverage)&#xD;
&#xD;
          -  Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive&#xD;
             consumption is defined as &gt;6 servings per day (1 serving contains approximately 120 mg&#xD;
             caffeine)&#xD;
&#xD;
          -  History and/or family history of congenital long QT syndrome, unexplained syncope, or&#xD;
             other additional risks of Torsade de Pointes or sudden premature death.&#xD;
&#xD;
          -  Any ECG abnormality considered to be clinically significant by the principal&#xD;
             investigator (PI)/designee;&#xD;
&#xD;
          -  Glomerular filtration rate (GFR) ≤80 mL/min/1.73 m2, as estimated by the Chronic&#xD;
             Kidney Disease Epidemiology Collaboration (CKD EPI) equation.&#xD;
&#xD;
          -  Ongoing liver disease or unexplained liver function test (LFT) elevations&#xD;
&#xD;
          -  History of hypersensitivity to β lactam antibiotics (including, but not limited to&#xD;
             imipenem)&#xD;
&#xD;
          -  History of significant multiple and/or severe allergies (including latex allergy);&#xD;
&#xD;
          -  Loss or donation of blood (approximately 500 mL) within 60 days prior to study drug&#xD;
             administration on Day 1, or donation of bone marrow or peripheral stem cells within 90&#xD;
             days prior to study drug administration on Day 1.&#xD;
&#xD;
          -  History of infectious disease within 28 days prior to study drug administration on Day&#xD;
             1 that, in the opinion of the investigator, would affect the subject's ability to&#xD;
             participate in the trial.&#xD;
&#xD;
          -  Venous access considered inadequate for PK sample collection and IV infusion; history&#xD;
             or evidence of adverse symptoms associated with IV access, phlebotomy, or blood&#xD;
             donation.&#xD;
&#xD;
          -  Employee or family member of the investigator, study site personnel, or sponsor.&#xD;
&#xD;
          -  Any other clinically relevant abnormality in the opinion of the investigators from the&#xD;
             following: medical and/or surgical history, physical examination, vital signs, 12-lead&#xD;
             ECG, serum chemistry, hematology, and urinalysis.&#xD;
&#xD;
          -  Any other reason that, in the opinion of the investigator, would render the subject&#xD;
             unsuitable for study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Le</last_name>
    <role>Study Chair</role>
    <affiliation>Evopoint Biosciences Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmaron CPC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>XNW4107</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_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/NCT04482569
org study id: XNW4107-001
nct id: NCT04482569
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a 3-part, first-in-human study to evaluate the safety, tolerability and
      pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy
      male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects
      will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with
      imipenem/cilastatin for 14 days.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Safety as assessed by number of participants experiencing adverse events
time frame: Change from baseline up to day 43 post-intervention
description: Number of participants who experience adverse events in different grades, as defined by Common Terminology for Adverse Events (CTCAE) v5.0
arm group label: Single Ascending Dose Study
arm group type: Experimental
description: Six XNW4107 doses ( 50-1250 mg ), each administered as a single dose with 60-minute IV infusion
arm group label: Multiple Ascending Dose Study
arm group type: Experimental
description: Three XNW4107 doses (167-500 mg), each administered as 60-minute IV infusion every 6 hours for 7 days
arm group label: Multiple Dose Study of XNW4107 +Imipenem/Cilastatin
arm group type: Experimental
description: 500 mg XNW4107 co-administered with imipenem/cilastatin as 60-minute IV infusion every 6 hours for 14 days
intervention type: Drug
intervention name: XNW4107
description: Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin
arm group label: Multiple Ascending Dose Study
arm group label: Multiple Dose Study of XNW4107 +Imipenem/Cilastatin
arm group label: Single Ascending Dose Study
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Le
role: Study Chair
affiliation: Evopoint Biosciences Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bacterial Infections