<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/NCT03303924</url>
  </required_header>
  <id_info>
    <org_study_id>CS2514-2017-0001</org_study_id>
    <nct_id>NCT03303924</nct_id>
  </id_info>
  <brief_title>Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects</brief_title>
  <official_title>A Phase I Study to Determine and Compare Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous ETX2514 and Sulbactam Administered to Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Entasis Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Entasis Therapeutics</source>
  <oversight_info>
    <has_dmc>No</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 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult&#xD;
      male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and&#xD;
      alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects&#xD;
      after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0&#xD;
      g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be&#xD;
      collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and&#xD;
      6.0 hours after start of the third dose (last dose) administered on Day 2.&#xD;
&#xD;
      Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in&#xD;
      the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the&#xD;
      infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.&#xD;
&#xD;
      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory&#xD;
      tests, ECG, physical examination, and vital sign monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">October 26, 2017</completion_date>
  <primary_completion_date type="Actual">October 17, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean maximum observed drug concentration (Cmax) in blood</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Cmax in epithelial lining fluid (ELF)</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean area under the curve (AUC) 0-6h in blood</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>AUC0-6h defined as the area under the concentration versus time curve from time zero to 6 hours postdose. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean terminal half-life (t1/2) in blood</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean volume of distribution in the terminal elimination phase (Vdss) in blood</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2 .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean clearance (CL) in blood</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose, and 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third (last) dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of AUC 0-6 for ELF to the corresponding AUC0-6 Plasma</measure>
    <time_frame>Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2</time_frame>
    <description>defined as the area under the concentration versus time curve from time zero to 6 hours. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2. Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours after the 3 dose (last dose) on Day 2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any non serious adverse event (AE)</measure>
    <time_frame>Day 1-14</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any serious adverse event (SAE)</measure>
    <time_frame>Day 1- 14</time_frame>
    <description>An SAE is defined as any event that results in death; is immediately life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in electrocardiogram (ECG) parameters at the indicated time points</measure>
    <time_frame>Day 1, 2, and 4</time_frame>
    <description>Change in baseline is calculated as the post-baseline value minus the baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in vital signs at the indicated time points</measure>
    <time_frame>Days 1, 2,and 4</time_frame>
    <description>change from baseline in calculated as the post baseline value minus the Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal, clinical significant hematology and chemistry laboratory values at the indicated time points</measure>
    <time_frame>Day 1-14</time_frame>
    <description>Change from baseline is calculated as the post-Baseline value minus the Baseline value</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ETX2514 and sulbactam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy male and female subjects, non-smoking, will receive multiple doses of ETX2514 1.0 g and sulbactam 1 g via intravenous (IV) infusion every 6 hours with each dose of medication infused over 3 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ETX2514 and sulbactam</intervention_name>
    <description>Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours</description>
    <arm_group_label>ETX2514 and sulbactam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female subject, between 18 and 55 years of age (both inclusive) at the&#xD;
             time of screening.&#xD;
&#xD;
          2. Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 and weight between 55.0 and 100.0&#xD;
             kg (both inclusive).&#xD;
&#xD;
          3. Be in general good health without clinically significant medical history as judged by&#xD;
             the Principal Investigator.&#xD;
&#xD;
          4. Provide voluntary written informed consent prior to any study procedures and is&#xD;
             willing and able to comply with the prescribed treatment protocol and evaluations.&#xD;
&#xD;
          5. Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to&#xD;
             screening.&#xD;
&#xD;
          6. Clinical laboratory values within the normal limits as defined by the clinical&#xD;
             laboratory, unless the Principal or sub-Investigator decides that out-of-range values&#xD;
             are not clinically significant.&#xD;
&#xD;
          7. If male, agree to be sexually abstinent or agree to use two approved methods of&#xD;
             contraception when engaging in sexual activity from screening until 90 days following&#xD;
             the last administration of the study drug, and to not donate sperm during same time&#xD;
             period. In the event that the sexual partner is surgically sterile, contraception is&#xD;
             not necessary.&#xD;
&#xD;
          8. Female subjects of child bearing potential must agree to practice two highly effective&#xD;
             methods of birth control (as determined by the Investigator; one of the methods must&#xD;
             be a barrier technique) from Screening until 30 days after the last dose of study&#xD;
             drug.&#xD;
&#xD;
          9. Postmenopausal females (defined as 12 months spontaneous amenorrhea) with serum&#xD;
             follicle stimulating hormone levels ≥ 40 mlU/mL or females who have undergone one of&#xD;
             the following sterilization procedures at least 6 months prior to screening (and is&#xD;
             documented):&#xD;
&#xD;
               1. Bilateral tubal ligation&#xD;
&#xD;
               2. Hysterectomy&#xD;
&#xD;
               3. Hysterectomy with unilateral or bilateral oophorectomy&#xD;
&#xD;
               4. Bilateral oophorectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of any moderate or severe hypersensitivity or allergic reaction to any&#xD;
             β-lactam antimicrobial (e.g., penicillin, cephalosporin, sulbactam or carbapenem)&#xD;
&#xD;
          2. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic,&#xD;
             renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic,&#xD;
             neurological, or psychiatric disease.&#xD;
&#xD;
          3. Calculated creatinine clearance less than 60 mL/min (Cockcroft-Gault method) at&#xD;
             screening or confinement.&#xD;
&#xD;
          4. Positive alcohol breath test or urine drug screen test at screening or confinement.&#xD;
&#xD;
          5. Positive testing for HIV, Hepatitis B or Hepatitis C.&#xD;
&#xD;
          6. History or presence of alcohol or drug abuse within the 2 years prior to screening.&#xD;
&#xD;
          7. Excessive intake of alcohol, defined as an average daily intake of greater than three&#xD;
             units, or an average weekly intake of greater than 21 units (one unit is equivalent to&#xD;
             1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz)&#xD;
             of wine) in the last 6 months prior to screening.&#xD;
&#xD;
          8. History of allergic or other serious adverse reactions to lidocaine or amide&#xD;
             anesthetic agents.&#xD;
&#xD;
          9. Clinically significant pulmonary or any other disease that prevents a subject from&#xD;
             undergoing bronchoscopy with pulmonary lavage.&#xD;
&#xD;
         10. Spirometry results showing an forced expiratory volume at one second (FEV1) &lt;80% of&#xD;
             predicted.&#xD;
&#xD;
         11. Use of probenecid within 30 days before confinement.&#xD;
&#xD;
         12. Use of medication, except for acetaminophen which is allowed up to 3 days before&#xD;
             confinement. Multivitamins and vitamin C are allowed up to 7 days before confinement&#xD;
             (Day 1). All other medication (including over the counter medication, health&#xD;
             supplements, and herbal remedies such as St. John's Wort extract must have been&#xD;
             stopped at least 14 days prior to confinement), unless agreed as non-clinically&#xD;
             relevant by the Principal Investigator.&#xD;
&#xD;
         13. Engagement in strenuous activity within 96 hours of confinement (Day 1) until&#xD;
             discharge.&#xD;
&#xD;
         14. History of seizures, head injury or meningitis (e.g., epilepsy).&#xD;
&#xD;
         15. History of bleeding disorders.&#xD;
&#xD;
         16. History or evidence of difficulty in donating blood.&#xD;
&#xD;
         17. Use of any prescription medication (with the exception of hormonal contraceptives or&#xD;
             hormone replacement therapy for females) within 14 days prior to confinement.&#xD;
&#xD;
         18. Blood donation/plasma donation or significant blood loss (i.e., &gt;500 mL) within 60&#xD;
             days prior to screening.&#xD;
&#xD;
         19. Participation in another investigational drug or device study or treated with an&#xD;
             investigational drug within 30 days or five half-lives (whichever is longer) prior to&#xD;
             screening.&#xD;
&#xD;
         20. Females who are pregnant or lactating.&#xD;
&#xD;
         21. Surgery within the past three months prior to screening determined by the investigator&#xD;
             to be clinically relevant.&#xD;
&#xD;
         22. Any acute illness including clinically significant infection within 30 days prior to&#xD;
             screening.&#xD;
&#xD;
         23. Subjects who have any of the following abnormalities on laboratory values at screening&#xD;
             or prior confinement including:&#xD;
&#xD;
               1. White blood cell count &lt; 3,000/mm3, hemoglobin &lt; 11g/dL.&#xD;
&#xD;
               2. Absolute neutrophil count &lt;1,200/mm3, platelet count &lt;120,000/mm3.&#xD;
&#xD;
         24. Unwillingness or inability to comply with the study protocol for any other reason.&#xD;
&#xD;
         25. Use of caffeine or xanthine containing products, Seville oranges (sour), grapefruit or&#xD;
             grapefruit juice within 48 hours prior to study drug dosing.&#xD;
&#xD;
         26. Any other condition or prior therapy, which, in the opinion of the Principal&#xD;
             Investigator, would make the subject unsuitable for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pulmonary Associates, PA</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetic</keyword>
  <keyword>Bronchoalveolar Lavage</keyword>
  <keyword>Epithelial Lining Fluid</keyword>
  <keyword>Alveolar Macrophage</keyword>
  <keyword>Gram-negative bacterium</keyword>
  <keyword>Acinetobacter baumannii</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulbactam</mesh_term>
    <mesh_term>Durlobactam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03303924
org study id: CS2514-2017-0001
nct id: NCT03303924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult
      male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and
      alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects
      after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0
      g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses
Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be
      collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and
      6.0 hours after start of the third dose (last dose) administered on Day 2.

      Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in
      the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the
      infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.

      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory
      tests, ECG, physical examination, and vital sign monitoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Mean maximum observed drug concentration (Cmax) in blood
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
measure: Mean Cmax in epithelial lining fluid (ELF)
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours.
measure: Mean area under the curve (AUC) 0-6h in blood
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: AUC0-6h defined as the area under the concentration versus time curve from time zero to 6 hours postdose. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
measure: Mean terminal half-life (t1/2) in blood
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
measure: Mean volume of distribution in the terminal elimination phase (Vdss) in blood
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2 .
measure: Mean clearance (CL) in blood
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose, and 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third (last) dose.
measure: Ratio of AUC 0-6 for ELF to the corresponding AUC0-6 Plasma
time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
description: defined as the area under the concentration versus time curve from time zero to 6 hours. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2. Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours after the 3 dose (last dose) on Day 2.
measure: Number of participants with any non serious adverse event (AE)
time frame: Day 1-14
description: An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Number of participants with any serious adverse event (SAE)
time frame: Day 1- 14
description: An SAE is defined as any event that results in death; is immediately life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
measure: Change from Baseline in electrocardiogram (ECG) parameters at the indicated time points
time frame: Day 1, 2, and 4
description: Change in baseline is calculated as the post-baseline value minus the baseline value
measure: Change from baseline in vital signs at the indicated time points
time frame: Days 1, 2,and 4
description: change from baseline in calculated as the post baseline value minus the Baseline value
measure: Number of participants with abnormal, clinical significant hematology and chemistry laboratory values at the indicated time points
time frame: Day 1-14
description: Change from baseline is calculated as the post-Baseline value minus the Baseline value
arm group label: ETX2514 and sulbactam
arm group type: Experimental
description: Healthy male and female subjects, non-smoking, will receive multiple doses of ETX2514 1.0 g and sulbactam 1 g via intravenous (IV) infusion every 6 hours with each dose of medication infused over 3 hours.
intervention type: Drug
intervention name: ETX2514 and sulbactam
description: Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours
arm group label: ETX2514 and sulbactam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sulbactam
mesh term: Durlobactam
sharing ipd: No