<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/NCT04441905</url>
  </required_header>
  <id_info>
    <org_study_id>18-0006</org_study_id>
    <secondary_id>HHSN272201500006I</secondary_id>
    <nct_id>NCT04441905</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of SAR440894 vs Placebo</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Single Center, Single Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of SAR440894 vs Placebo in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults&#xD;
      aged 18 to 45, inclusive, will be recruited and admitted at one US site. Each subject will be&#xD;
      randomized to receive either SAR440894 or matching placebo via 60-minute intravenous&#xD;
      infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2&#xD;
      placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed&#xD;
      first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined&#xD;
      safety criteria in the preceding cohort. Each subject's participation will take place over&#xD;
      approximately 150 days, not including the screening visit. There are no hypotheses for this&#xD;
      phase I study. The primary objective will be to determine the safety of single ascending&#xD;
      intravenous (IV) infusions of SAR440894 when administered in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults&#xD;
      aged 18 to 45, inclusive, will be recruited and admitted at one US site. Each subject will be&#xD;
      randomized to receive either SAR440894 or matching placebo via 60-minute intravenous&#xD;
      infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2&#xD;
      placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed&#xD;
      first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined&#xD;
      safety criteria in the preceding cohort. Each subject's participation will take place over&#xD;
      approximately 150 days, not including the screening visit. There are no hypotheses for this&#xD;
      phase I study. The primary objective will be to determine the safety of single ascending&#xD;
      intravenous (IV) infusions of SAR440894 when administered in healthy adults. The secondary&#xD;
      objectives are: 1) to determine the pharmacokinetics (PK) of single ascending doses of&#xD;
      60-minute IV infusions SAR440894 in healthy adults and 2) to asses the immunogenicity of&#xD;
      single ascending doses of 60-minute IV infusions SAR440894 in healthy adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of adverse events (AEs)</measure>
    <time_frame>Day 1 through Day 150</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of changes from baseline in clinical safety laboratory values</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Clinical safety laboratory evaluations include hematology, chemistry, urinalysis, and coagulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of changes from baseline in vital signs</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Vitals signs include temperature, heart rate, blood pressure, and respiratory rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of clinically significant changes in ECG parameters from baseline</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Significant changes are defined as the following: Any significant change in rate or rhythm as determined by the site PI, QTcF interval of greater than 450 ms (male) or greater than 460 ms (female), Increase from the QTcF baseline (defined as median of pre-dose measurements) greater than 50 ms until the change resolves.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of serious adverse events (SAEs)</measure>
    <time_frame>Day 1 through Day 150</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in concentration of SAR440894 plasma human anti-drug antibody (ADA)</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Will be used to determine immunogenicity of SAR440894.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/absence of SAR440894 plasma human anti-drug antibody (ADA)</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Will be used to determine immunogenicity of SAR440894.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SAR440894 plasma concentration</measure>
    <time_frame>Day 1 through Day 150</time_frame>
    <description>Plasma concentration will be determined by using a validated enzyme-linked immunosorbent assay. Plasma concentrations will be used to determine plasma PK of SAR440894.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chikungunya Virus Infection</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One time 60-minute IV infusion of lyophilized placebo for SAR440894</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SAR440894</intervention_name>
    <description>One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be a healthy adult 18 to 45 years of age, inclusive, with a body mass index (BMI)&#xD;
             greater than 18 or less than 35 kg/m^2, inclusive.&#xD;
&#xD;
          2. Participants of childbearing potential* having vaginal intercourse must use an&#xD;
             effective method of contraception** from 30 days before study product administration&#xD;
             through the final study visit.&#xD;
&#xD;
             *Not sterilized via hysterectomy or bilateral oophorectomy and/or salpingectomy or be&#xD;
             less than 1 year from the last menses if menopausal.&#xD;
&#xD;
             **Includes any of the following (a) exclusive non-male sexual relationships; (b)&#xD;
             monogamous relationship with vasectomized partner (greater than or equal to 180 days&#xD;
             between procedure and subject receipt of investigational product); (c) bilateral tubal&#xD;
             ligation or tubal occlusion (Essure(R)) with documented radiographic confirmation at&#xD;
             90 days; (d) effective intrauterine device (IUD); (e) hormonal implants (Implanon(R));&#xD;
             (f) other hormonal contraceptives (such as birth control pills, vaginal rings, patches&#xD;
             or injections); (g) barrier methods (condom, diaphragm, cervical cap) PLUS spermicide&#xD;
             (gel or foam)&#xD;
&#xD;
          3. Women of childbearing potential must agree not to donate ova or oocytes (ie, human&#xD;
             eggs) during the study.&#xD;
&#xD;
          4. Male subjects (including those with vasectomies) whose partners are of childbearing&#xD;
             potential should use condoms with spermicide and not donate sperm for the duration of&#xD;
             the study.&#xD;
&#xD;
          5. Must have adequate venous access for IV infusions and blood draws.&#xD;
&#xD;
          6. Agrees to be available for all study visits and willing to cooperate fully with the&#xD;
             requirements* of the study protocol.&#xD;
&#xD;
             *Requirements include remaining in confinement for at least 72 hours after receiving&#xD;
             study product and other activities outlined in the protocol's Schedule of Events.&#xD;
&#xD;
          7. Is able to understand the informed consent process and procedures and signs the&#xD;
             consent form.&#xD;
&#xD;
          8. Will agree not to donate any blood or blood products* for the duration of the study.&#xD;
&#xD;
               -  Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.&#xD;
&#xD;
          9. Will agree to avoid travel to endemic areas (as defined by the Center for Disease&#xD;
             Control (CDC)) for Chikungunya virus at any point during the follow-up period.&#xD;
             https://www.cdc.gov/chikungunya/geo/index.html&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any medical condition (e.g., renal dysfunction) that, in the opinion of the site&#xD;
             PI or appropriate sub-investigator listed on Food and Drug Administration (FDA) Form&#xD;
             1572, is a contraindication to study participation.&#xD;
&#xD;
          2. Has any clinically significant (CS) electrocardiogram (ECG) abnormalities in the&#xD;
             opinion of the site Principal Investigator (PI) or appropriate sub-investigator been&#xD;
             listed on FDA Form 1572?&#xD;
&#xD;
          3. Use of any prohibited prescription medication (excluding contraceptives in females)&#xD;
             within 14 days before study product administration, through Day 56* *Prohibited&#xD;
             medications include immunosuppressives; immune modulators; oral corticosteroids&#xD;
             (topical/intranasal steroids are acceptable); prescription Non-Steroidal&#xD;
             Anti-inflammatory Drugs (NSAIDs); anti-neoplastic agents; any vaccine (licensed or&#xD;
             investigational). If study activities overlap with the influenza season, subjects will&#xD;
             be instructed to obtain influenza vaccine at least 30 days prior to proposed dosing or&#xD;
             delay vaccination until after Day 56. Subjects will be instructed to obtain the last&#xD;
             dose of any vaccine for SARS-CoV-2 (COVID-19) at least 30 days prior to proposed&#xD;
             dosing or delay vaccination until after Day 56.&#xD;
&#xD;
          4. Use of nonprescription systemic drugs within 7 days before study product&#xD;
             administration (includes vitamins, antacids*, over-the-counter drugs**, herbal/dietary&#xD;
             supplements, etc.) through Day 28***&#xD;
&#xD;
             *Nonprescription drugs and supplements may be allowed before Day 28 at the discretion&#xD;
             of the site PI.&#xD;
&#xD;
             **Includes proton pump inhibitors and H2-blockers (Histamine-2 blockers)&#xD;
&#xD;
             ***Nonprescription drugs and supplements may be allowed before Day 28 at the&#xD;
             discretion of the site PI.&#xD;
&#xD;
          5. Hypertension, with confirmed systolic blood pressure (BP) greater than 140 mm Hg or&#xD;
             confirmed diastolic BP greater than 90 mm Hg, measured after 5 minutes of rest at&#xD;
             screening.&#xD;
&#xD;
          6. Hypotension, with confirmed systolic BP less than 90 mm Hg.&#xD;
&#xD;
          7. Resting heart rate (HR) less than 45 bpm or greater than 100 bpm at screening.&#xD;
&#xD;
          8. Body weight less than 50 kg.&#xD;
&#xD;
          9. History of a significant illness, per the investigators' clinical judgment, within 2&#xD;
             weeks before dosing (subjects can screen after illness is resolved for 2 weeks).&#xD;
&#xD;
         10. Known diagnosis of prolonged QT interval, congenital long QT syndrome,&#xD;
             bradyarrhythmias, or uncompensated heart failure.&#xD;
&#xD;
         11. Males with a median QTcF greater than 450 msec or females with a median QTcF greater&#xD;
             than 460 msec (Fridericia's correction) at Screening.* *ECG tracings should be&#xD;
             recorded at least 1 minute apart, after at least 5 minutes of rest in the supine&#xD;
             position. If the median QTcF value from the 3 tracings exceeds the limits stated, the&#xD;
             subject is disqualified.&#xD;
&#xD;
         12. Any history of malignancy ever, except low-grade skin cancer (ie, basal cell carcinoma&#xD;
             thought to be cured).&#xD;
&#xD;
         13. History of drug abuse, alcohol abuse, or significant psychiatric history according to&#xD;
             the investigators' judgment within 12 months before Screening.&#xD;
&#xD;
         14. Positive screen for hepatitis B virus surface antigen, hepatitis C virus antibody, or&#xD;
             human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
         15. Excessive consumption of beverages containing xanthine bases, or more than 400 mg of&#xD;
             caffeine per day within 1 week of study product administration through the final study&#xD;
             visit.&#xD;
&#xD;
         16. Consumption of alcohol within 24 hours before study product administration.&#xD;
&#xD;
         17. Use of nicotine-containing products within 30 days before study product administration&#xD;
             through the final study visit.&#xD;
&#xD;
         18. Positive drug screen*, positive cotinine screen, or positive breathalyzer test for&#xD;
             alcohol at Screening or admission (Day -1).&#xD;
&#xD;
             *Cannabinoids, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and&#xD;
             phencyclidine. Subjects should be notified by phone not to consume any poppy seeds&#xD;
             within 24 hours before the screening urine test to avoid a false positive opioid test&#xD;
             result.&#xD;
&#xD;
         19. If female, serum positive pregnancy test at Screening or serum positive pregnancy test&#xD;
             on Day -1.&#xD;
&#xD;
         20. Breastfeeding throughout the duration of the study&#xD;
&#xD;
         21. Total WBC and platelet counts, hemoglobin*, total bilirubin*, alanine/aspartate&#xD;
             aminotransferase and sodium* are Grade 1 or higher** at Screening visit.&#xD;
&#xD;
             *For sodium; lower limit values of 133-134 mmol/L will be allowed at Screening and Day&#xD;
             -1/baseline. If the result at screening is 132 mmol/L or below , the participant will&#xD;
             be scheduled to repeat the test during the screening period but before Day-1 to assure&#xD;
             that it is at or &gt; 133 mmol/L Repeated sodium values of 132 mmol/L and below are&#xD;
             exclusionary. Potential subjects excluded prior to Protocol Version 6.0 with Grade 1&#xD;
             sodium values may be rescreened.&#xD;
&#xD;
             For hemoglobin; a lower limit of 13.5 g/dL for males and 11.5 mg/dL for females is&#xD;
             allowable at Screening. Hemoglobin values of 13.4 mg/dL and below for males and 11.4&#xD;
             mg/dL and below for females are exclusionary at Screening.&#xD;
&#xD;
             For total bilirubin; upper limit values of 1.2 mg/dL will be allowed at Screening and&#xD;
             Day -1/baseline provided the AST and ALT are within normal limits. Total bilirubin&#xD;
             values of 1.3mg/dL and above are exclusionary. Potential subjects excluded prior to&#xD;
             Protocol Version 6.0 with bilirubin values below the Version 6.0 upper limit may be&#xD;
             rescreened.&#xD;
&#xD;
             **Grade 1 or higher toxicity, see Appendix C or Appendix D. Safety laboratory tests&#xD;
             drawn on Day -1 or Screening if within 48 hours of planned dosing will serve as&#xD;
             baseline values. Day -1 laboratory tests with a Grade 1 severity, other than those&#xD;
             noted above, will not exclude subjects from participation.&#xD;
&#xD;
         22. Potassium, bicarbonate or creatinine results are Grade 1 or higher at either Screening&#xD;
             or Day -1/Baseline visits.&#xD;
&#xD;
         23. Received an experimental agent (vaccine, drug, biologic, device, or medication) within&#xD;
             30 days or 5 half-lives (whichever is longer) before study product administration.*&#xD;
&#xD;
             *Prior participation at any time in noninvasive methodology trials in which no drugs&#xD;
             were given is acceptable.&#xD;
&#xD;
         24. Is participating in or plans to participate in another clinical trial with an&#xD;
             interventional agent that will be received during this trial.&#xD;
&#xD;
         25. Has donated more than 500 mL of blood or blood products* within the month before&#xD;
             Screening.&#xD;
&#xD;
             *Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.&#xD;
&#xD;
         26. Has a history of serologically-proven Chikungunya virus (CHIKV) exposure at any point,&#xD;
             or positive anti CHIKV antibodies at Screening.&#xD;
&#xD;
         27. Has received blood products within 120 days prior to Screening.&#xD;
&#xD;
         28. Has received any mAb in the past, whether licensed or investigational, or plans to&#xD;
             receive a mAb during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael Cohen-Wolkowiez</last_name>
    <phone>19196688812</phone>
    <email>michael.cohenwolkowiez@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johnson County Clin-Trials (JCCT)</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chikungunya Virus</keyword>
  <keyword>dose escalation</keyword>
  <keyword>healthy adults</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>phase 1</keyword>
  <keyword>placebo</keyword>
  <keyword>SAR440894</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chikungunya Fever</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/NCT04441905
org study id: 18-0006
secondary id: HHSN272201500006I
nct id: NCT04441905
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults
      aged 18 to 45, inclusive, will be recruited and admitted at one US site. Each subject will be
      randomized to receive either SAR440894 or matching placebo via 60-minute intravenous
      infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2
      placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed
      first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined
      safety criteria in the preceding cohort. Each subject's participation will take place over
      approximately 150 days, not including the screening visit. There are no hypotheses for this
      phase I study. The primary objective will be to determine the safety of single ascending
      intravenous (IV) infusions of SAR440894 when administered in healthy adults.
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults
      aged 18 to 45, inclusive, will be recruited and admitted at one US site. Each subject will be
      randomized to receive either SAR440894 or matching placebo via 60-minute intravenous
      infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2
      placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed
      first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined
      safety criteria in the preceding cohort. Each subject's participation will take place over
      approximately 150 days, not including the screening visit. There are no hypotheses for this
      phase I study. The primary objective will be to determine the safety of single ascending
      intravenous (IV) infusions of SAR440894 when administered in healthy adults. The secondary
      objectives are: 1) to determine the pharmacokinetics (PK) of single ascending doses of
      60-minute IV infusions SAR440894 in healthy adults and 2) to asses the immunogenicity of
      single ascending doses of 60-minute IV infusions SAR440894 in healthy adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Occurrence of adverse events (AEs)
time frame: Day 1 through Day 150
measure: Occurrence of changes from baseline in clinical safety laboratory values
time frame: Day 1 through Day 150
description: Clinical safety laboratory evaluations include hematology, chemistry, urinalysis, and coagulation.
measure: Occurrence of changes from baseline in vital signs
time frame: Day 1 through Day 150
description: Vitals signs include temperature, heart rate, blood pressure, and respiratory rate.
measure: Occurrence of clinically significant changes in ECG parameters from baseline
time frame: Day 1 through Day 150
description: Significant changes are defined as the following: Any significant change in rate or rhythm as determined by the site PI, QTcF interval of greater than 450 ms (male) or greater than 460 ms (female), Increase from the QTcF baseline (defined as median of pre-dose measurements) greater than 50 ms until the change resolves.
measure: Occurrence of serious adverse events (SAEs)
time frame: Day 1 through Day 150
measure: Changes in concentration of SAR440894 plasma human anti-drug antibody (ADA)
time frame: Day 1 through Day 150
description: Will be used to determine immunogenicity of SAR440894.
measure: Presence/absence of SAR440894 plasma human anti-drug antibody (ADA)
time frame: Day 1 through Day 150
description: Will be used to determine immunogenicity of SAR440894.
measure: SAR440894 plasma concentration
time frame: Day 1 through Day 150
description: Plasma concentration will be determined by using a validated enzyme-linked immunosorbent assay. Plasma concentrations will be used to determine plasma PK of SAR440894.
arm group label: Cohort 1
arm group type: Experimental
description: 0.3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
arm group label: Cohort 2
arm group type: Experimental
description: 1 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
arm group label: Cohort 3
arm group type: Experimental
description: 3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
arm group label: Cohort 4
arm group type: Experimental
description: 10 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
arm group label: Cohort 5
arm group type: Experimental
description: 20 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
intervention type: Other
intervention name: Placebo
description: One time 60-minute IV infusion of lyophilized placebo for SAR440894
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
intervention type: Biological
intervention name: SAR440894
description: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Cohen-Wolkowiez
phone: 19196688812
email: michael.cohenwolkowiez@duke.edu
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Chikungunya Fever