<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/NCT03762031</url>
  </required_header>
  <id_info>
    <org_study_id>GTI-4711-002</org_study_id>
    <nct_id>NCT03762031</nct_id>
  </id_info>
  <brief_title>A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galera Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galera Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose&#xD;
      escalation study designed to evaluate the safety and PK of intravenously administered&#xD;
      superoxide dismutase mimetic GC4711 in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities</measure>
    <time_frame>From randomization through study completion (estimated up to 3 days)</time_frame>
    <description>Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>GC4711 30mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GC4711 60mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GC4711 90mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GC4711 120mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GC4711 75mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GC4711 105mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 30mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 30mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 60mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 60mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 90mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 90mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 120mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 120mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>single dose of normal saline given via a 15 minute intravenous infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 75mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 75mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC4711 105mg</intervention_name>
    <description>single dose given via a 15 minute intravenous infusion</description>
    <arm_group_label>GC4711 105mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy men and women between 18 and 50 years&#xD;
&#xD;
          2. Subjects who provide written informed consent&#xD;
&#xD;
          3. Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg&#xD;
&#xD;
          4. Subjects in general good health&#xD;
&#xD;
          5. Blood pressure and pulse within normal limits&#xD;
&#xD;
          6. Male subjects must practice effective contraception&#xD;
&#xD;
          7. Female subjects must:&#xD;
&#xD;
               -  Have a negative serum pregnancy test during&#xD;
&#xD;
               -  Be non-lactating;&#xD;
&#xD;
               -  Be at least 2 years postmenopausal, surgically sterile, or practicing effective&#xD;
                  contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of clinically significant illness or medical history which would preclude them&#xD;
             from the study.&#xD;
&#xD;
          2. Known contraindication, hypersensitivity and/or allergy to study drugs&#xD;
&#xD;
          3. Use of any prescription or over-the-counter medication within one week prior to study&#xD;
             drug administration&#xD;
&#xD;
          4. Anticipated need for any medication during the study&#xD;
&#xD;
          5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5)&#xD;
             inhibitors&#xD;
&#xD;
          6. Use of other drugs that may, in the judgment of the Investigator, create a risk for a&#xD;
             precipitous decrease in blood pressure&#xD;
&#xD;
          7. Presence of orthostatic hypotension at screening&#xD;
&#xD;
          8. Use of any vitamin or mineral supplement 24 hours before dosing or throughout study&#xD;
&#xD;
          9. Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)&#xD;
&#xD;
         10. Known history of substance abuse, drug addiction, or alcoholism within 3 years&#xD;
&#xD;
         11. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours&#xD;
             before the administration of study drug and throughout the the study;&#xD;
&#xD;
         12. Positive drug and alcohol toxicology screens during Screening&#xD;
&#xD;
         13. History of smoking or any use of a tobacco product within 6 months&#xD;
&#xD;
         14. Donation of blood or blood products within 30 days before Baseline and throughout the&#xD;
             study;&#xD;
&#xD;
         15. Mentally unstable or incapable of being compliant with the protocol&#xD;
&#xD;
         16. Receipt of an investigational test substance within 3 months before the administration&#xD;
             of study drugs, or anticipated receiving any study drugs&#xD;
&#xD;
         17. Subject has previously participated in this study, or in a prior Galera study&#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>Jon Holmlund, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Galera Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</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/NCT03762031
org study id: GTI-4711-002
nct id: NCT03762031
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose
      escalation study designed to evaluate the safety and PK of intravenously administered
      superoxide dismutase mimetic GC4711 in healthy volunteers.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
time frame: From randomization through study completion (estimated up to 3 days)
description: Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities
arm group label: GC4711 30mg
arm group type: Experimental
arm group label: GC4711 60mg
arm group type: Experimental
arm group label: GC4711 90mg
arm group type: Experimental
arm group label: GC4711 120mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: GC4711 75mg
arm group type: Experimental
arm group label: GC4711 105mg
arm group type: Experimental
intervention type: Drug
intervention name: GC4711 30mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 30mg
intervention type: Drug
intervention name: GC4711 60mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 60mg
intervention type: Drug
intervention name: GC4711 90mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 90mg
intervention type: Drug
intervention name: GC4711 120mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 120mg
intervention type: Drug
intervention name: Placebo
description: single dose of normal saline given via a 15 minute intravenous infusion
arm group label: Placebo
intervention type: Drug
intervention name: GC4711 75mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 75mg
intervention type: Drug
intervention name: GC4711 105mg
description: single dose given via a 15 minute intravenous infusion
arm group label: GC4711 105mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jon Holmlund, MD
role: Study Chair
affiliation: Galera Therapeutics, Inc.
facility: 
country: Australia
responsible party type: Sponsor
sharing ipd: No