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/NCT05970718</url>
    </required_header>
    <id_info>
      <org_study_id>R7544-HV-22109</org_study_id>
      <nct_id>NCT05970718</nct_id>
    </id_info>
    <brief_title>A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Regeneron Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Regeneron Pharmaceuticals</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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 is researching an experimental drug called REGN7544.The study is focused on healthy&#xD;
        adults. The aim of the study is to see how safe and tolerable the study drug is in healthy&#xD;
        adults.&#xD;
  &#xD;
        The study is looking at several other research questions, including:&#xD;
  &#xD;
          -  What side effects may happen from taking the study drug&#xD;
  &#xD;
          -  How much study drug is in your blood at different times&#xD;
  &#xD;
          -  Whether the body makes antibodies against the study drug (which could make the drug less&#xD;
             effective or could lead to side effects)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 18, 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>
      <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 (TEAEs)</measure>
      <time_frame>Through approximately day 162</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of TEAEs</measure>
      <time_frame>Through approximately day 162</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Systolic Blood Pressure (SBP)</measure>
      <time_frame>Through day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Diastolic Blood Pressure (DBP)</measure>
      <time_frame>Through day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Mean Arterial Pressure (MAP)</measure>
      <time_frame>Through day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pulse Pressure (PP)</measure>
      <time_frame>Through day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentrations of REGN7544 in serum over time</measure>
      <time_frame>Through approximately day 162</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent Anti-Drug Antibody (ADA)</measure>
      <time_frame>Through approximately day 162</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Titer of ADA</measure>
      <time_frame>Through approximately day 162</time_frame>
    </secondary_outcome>
    <number_of_arms>11</number_of_arms>
    <enrollment type="Anticipated">88</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>IV Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV Dose Level 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV Dose Level 5</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV Dose Level 6</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending IV dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SC Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending SC dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SC Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending SC dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SC Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending SC dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Optional Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Optional Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>REGN7544</intervention_name>
      <description>Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration</description>
      <arm_group_label>IV Dose Level 1</arm_group_label>
      <arm_group_label>IV Dose Level 2</arm_group_label>
      <arm_group_label>IV Dose Level 3</arm_group_label>
      <arm_group_label>IV Dose Level 4</arm_group_label>
      <arm_group_label>IV Dose Level 5</arm_group_label>
      <arm_group_label>IV Dose Level 6</arm_group_label>
      <arm_group_label>Optional Cohort 1</arm_group_label>
      <arm_group_label>Optional Cohort 2</arm_group_label>
      <arm_group_label>SC Dose Level 1</arm_group_label>
      <arm_group_label>SC Dose Level 2</arm_group_label>
      <arm_group_label>SC Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Matching Placebo</intervention_name>
      <description>Solution for single ascending IV or SC administration per the protocol</description>
      <arm_group_label>IV Dose Level 1</arm_group_label>
      <arm_group_label>IV Dose Level 2</arm_group_label>
      <arm_group_label>IV Dose Level 3</arm_group_label>
      <arm_group_label>IV Dose Level 4</arm_group_label>
      <arm_group_label>IV Dose Level 5</arm_group_label>
      <arm_group_label>IV Dose Level 6</arm_group_label>
      <arm_group_label>Optional Cohort 1</arm_group_label>
      <arm_group_label>Optional Cohort 2</arm_group_label>
      <arm_group_label>SC Dose Level 1</arm_group_label>
      <arm_group_label>SC Dose Level 2</arm_group_label>
      <arm_group_label>SC Dose Level 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Has a body mass index between 18 and 32 kg/m^2&#xD;
  &#xD;
            2. Is judged by the investigator to be in good health based on medical history, physical&#xD;
               examination, vital sign measurements, and electrocardiograms (ECGs) performed at&#xD;
               screening and/or prior to administration of initial dose of study drug, as defined in&#xD;
               the protocol&#xD;
  &#xD;
            3. Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol&#xD;
  &#xD;
            4. Difference between semi-recumbent systolic blood pressure (SBP) measurements in left&#xD;
               and right arm less than 20 mmHg at screening visit&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. History of clinically significant cardiovascular, respiratory, hepatic, renal,&#xD;
               gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as&#xD;
               assessed by the investigator that may confound the results of the study or poses an&#xD;
               additional risk to the participant by study participation&#xD;
  &#xD;
            2. History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension&#xD;
               (BP &lt;90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension,&#xD;
               postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac&#xD;
               arrhythmia&#xD;
  &#xD;
            3. Presents any concern to the study investigator that might confound the results of the&#xD;
               study or poses an additional risk to the participant by their participation in the&#xD;
               study&#xD;
  &#xD;
            4. Was hospitalized (ie, &gt;24 hours) for any reason within 30 days of screening&#xD;
  &#xD;
            5. Is a current smoker or former smoker, including e-cigarettes, who stopped smoking&#xD;
               within 3 months prior to screening&#xD;
  &#xD;
          NOTE: Other protocol defined inclusion / exclusion criteria apply&#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>
    <overall_official>
      <last_name>Clinical Trial Management</last_name>
      <role>Study Director</role>
      <affiliation>Regeneron Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Administrator</last_name>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>New Zealand Clinical Research</name>
        <address>
          <city>Christchurch</city>
          <zip>8011</zip>
          <country>New Zealand</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>New Zealand</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hypotension and/or hypovolemia</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf</ipd_access_criteria>
      <ipd_url>https://vivli.org/</ipd_url>
    </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/NCT05970718
  org study id: R7544-HV-22109
  nct id: NCT05970718
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is researching an experimental drug called REGN7544.The study is focused on healthy
        adults. The aim of the study is to see how safe and tolerable the study drug is in healthy
        adults.
  
        The study is looking at several other research questions, including:
  
          -  What side effects may happen from taking the study drug
  
          -  How much study drug is in your blood at different times
  
          -  Whether the body makes antibodies against the study drug (which could make the drug less
             effective or could lead to side effects)
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
  time frame: Through approximately day 162
  measure: Severity of TEAEs
  time frame: Through approximately day 162
  measure: Changes from baseline in Systolic Blood Pressure (SBP)
  time frame: Through day 6
  measure: Changes from baseline in Diastolic Blood Pressure (DBP)
  time frame: Through day 6
  measure: Changes from baseline in Mean Arterial Pressure (MAP)
  time frame: Through day 6
  measure: Changes from baseline in Pulse Pressure (PP)
  time frame: Through day 6
  measure: Concentrations of REGN7544 in serum over time
  time frame: Through approximately day 162
  measure: Incidence of treatment-emergent Anti-Drug Antibody (ADA)
  time frame: Through approximately day 162
  measure: Titer of ADA
  time frame: Through approximately day 162
  arm group label: IV Dose Level 1
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: IV Dose Level 2
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: IV Dose Level 3
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: IV Dose Level 4
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: IV Dose Level 5
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: IV Dose Level 6
  arm group type: Experimental
  description: Randomized 6:2 for single ascending IV dose
  arm group label: SC Dose Level 1
  arm group type: Experimental
  description: Randomized 6:2 for single ascending SC dose
  arm group label: SC Dose Level 2
  arm group type: Experimental
  description: Randomized 6:2 for single ascending SC dose
  arm group label: SC Dose Level 3
  arm group type: Experimental
  description: Randomized 6:2 for single ascending SC dose
  arm group label: Optional Cohort 1
  arm group type: Experimental
  description: Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level
  arm group label: Optional Cohort 2
  arm group type: Experimental
  description: Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level
  intervention type: Drug
  intervention name: REGN7544
  description: Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration
  arm group label: IV Dose Level 1
  arm group label: IV Dose Level 2
  arm group label: IV Dose Level 3
  arm group label: IV Dose Level 4
  arm group label: IV Dose Level 5
  arm group label: IV Dose Level 6
  arm group label: Optional Cohort 1
  arm group label: Optional Cohort 2
  arm group label: SC Dose Level 1
  arm group label: SC Dose Level 2
  arm group label: SC Dose Level 3
  intervention type: Drug
  intervention name: Matching Placebo
  description: Solution for single ascending IV or SC administration per the protocol
  arm group label: IV Dose Level 1
  arm group label: IV Dose Level 2
  arm group label: IV Dose Level 3
  arm group label: IV Dose Level 4
  arm group label: IV Dose Level 5
  arm group label: IV Dose Level 6
  arm group label: Optional Cohort 1
  arm group label: Optional Cohort 2
  arm group label: SC Dose Level 1
  arm group label: SC Dose Level 2
  arm group label: SC Dose Level 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Trial Management
  role: Study Director
  affiliation: Regeneron Pharmaceuticals
  last name: Clinical Trials Administrator
  phone: 844-734-6643
  email: clinicaltrials@regeneron.com
  facility: 
  status: Recruiting
  country: New Zealand
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
  ipd access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
  ipd url: https://vivli.org/