<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/NCT03832517</url>
  </required_header>
  <id_info>
    <org_study_id>RC-01-001</org_study_id>
    <nct_id>NCT03832517</nct_id>
  </id_info>
  <brief_title>Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01</brief_title>
  <official_title>A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Recida Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Recida 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>
      A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01).&#xD;
      In Part 1 cohorts of healthy adults will participate in a single dose escalation study of&#xD;
      increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate&#xD;
      in a multiple dose escalation study of increasing intravenous doses of RC-01 given either&#xD;
      twice daily or three times daily.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    safety&#xD;
  </why_stopped>
  <start_date type="Actual">April 14, 2019</start_date>
  <completion_date type="Actual">May 8, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 2019</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with a treatment-related adverse event collected over the duration of the study</measure>
    <time_frame>Up to the final follow-up 1 day visit</time_frame>
    <description>Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration time data for RC-01 and metabolites</measure>
    <time_frame>Pre-dose through 24 hours after the final infusion of study drug</time_frame>
    <description>Individual and mean plasma concentration time data for RC-01 and its metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability of RC-01 and other RC-01 metabolites</measure>
    <time_frame>Pre-dose through 24 hours after the final infusion of study drug</time_frame>
    <description>Levels of RC-01 and metabolites in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration</measure>
    <time_frame>Pre-dose through 24 hours after the final infusion of study drug</time_frame>
    <description>Levels of RC-01 and its metabolites in the urine</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Safety</condition>
  <arm_group>
    <arm_group_label>Single intravenous doses of RC-01</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single escalating doses of RC-01 from 200 mg to 1600 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single intravenous doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intravenous doses of placebo to match RC-01</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple intravenous doses of RC-01</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple intravenous doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two or three times daily intravenous doses of placebo to match RC-01</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single intravenous doses of RC-01</intervention_name>
    <description>Intravenous single escalating doses of RC-01</description>
    <arm_group_label>Single intravenous doses of RC-01</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single intravenous doses of placebo</intervention_name>
    <description>Intravenous single doses of placebo to match RC-01</description>
    <arm_group_label>Single intravenous doses of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple intravenous doses of RC-01</intervention_name>
    <description>Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days</description>
    <arm_group_label>Multiple intravenous doses of RC-01</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple intravenous doses of placebo</intervention_name>
    <description>Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days</description>
    <arm_group_label>Multiple intravenous doses of placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
          -  Agrees to be available for all study visits and cooperate fully with the requirements&#xD;
             of the study protocol, including the schedule of assessments&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders&#xD;
&#xD;
          -  Unable to cooperate fully with the requirements of the study protocol, including the&#xD;
             schedule of assessments, or likely to be non-compliant with any study requirements&#xD;
&#xD;
          -  Women who are pregnant and/or nursing&#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>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 24, 2019</last_update_submitted>
  <last_update_submitted_qc>May 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03832517
org study id: RC-01-001
nct id: NCT03832517
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01).
      In Part 1 cohorts of healthy adults will participate in a single dose escalation study of
      increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate
      in a multiple dose escalation study of increasing intravenous doses of RC-01 given either
      twice daily or three times daily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with a treatment-related adverse event collected over the duration of the study
time frame: Up to the final follow-up 1 day visit
description: Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)
measure: Plasma concentration time data for RC-01 and metabolites
time frame: Pre-dose through 24 hours after the final infusion of study drug
description: Individual and mean plasma concentration time data for RC-01 and its metabolites
measure: Bioavailability of RC-01 and other RC-01 metabolites
time frame: Pre-dose through 24 hours after the final infusion of study drug
description: Levels of RC-01 and metabolites in blood
measure: Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration
time frame: Pre-dose through 24 hours after the final infusion of study drug
description: Levels of RC-01 and its metabolites in the urine
arm group label: Single intravenous doses of RC-01
arm group type: Active Comparator
description: Single escalating doses of RC-01 from 200 mg to 1600 mg
arm group label: Single intravenous doses of placebo
arm group type: Placebo Comparator
description: Single intravenous doses of placebo to match RC-01
arm group label: Multiple intravenous doses of RC-01
arm group type: Active Comparator
description: Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined
arm group label: Multiple intravenous doses of placebo
arm group type: Placebo Comparator
description: Two or three times daily intravenous doses of placebo to match RC-01
intervention type: Drug
intervention name: Single intravenous doses of RC-01
description: Intravenous single escalating doses of RC-01
arm group label: Single intravenous doses of RC-01
intervention type: Drug
intervention name: Single intravenous doses of placebo
description: Intravenous single doses of placebo to match RC-01
arm group label: Single intravenous doses of placebo
intervention type: Drug
intervention name: Multiple intravenous doses of RC-01
description: Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
arm group label: Multiple intravenous doses of RC-01
intervention type: Drug
intervention name: Multiple intravenous doses of placebo
description: Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days
arm group label: Multiple intravenous doses of placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No