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/NCT05981976</url>
    </required_header>
    <id_info>
      <org_study_id>IM101-920</org_study_id>
      <nct_id>NCT05981976</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants</brief_title>
    <official_title>A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</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>
        The purpose of this study is to compare the relative absorption of abatacept in healthy&#xD;
        participants following subcutaneous (SC) administration in which the drug substance is&#xD;
        manufactured with the current or new process.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 25, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum observed serum concentration (Cmax)</measure>
      <time_frame>Up to Day 71</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))</measure>
      <time_frame>Up to Day 71</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))</measure>
      <time_frame>Up to Day 71</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to Day 71</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))</measure>
      <time_frame>Up to Day 71</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration at 168 hours after dosing (C168)</measure>
      <time_frame>Up to Day 71</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of maximum observed serum concentration (Tmax)</measure>
      <time_frame>Up to Day 71</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of laboratory-reported positive responses of anti-abatacept antibodies</measure>
      <time_frame>Up to Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of laboratory-reported positive responses of anti-CTLA4-T antibodies</measure>
      <time_frame>Up to Day 71</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">174</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Abatacept Treatment A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Abatacept Treatment B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Abatacept</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Abatacept Treatment A</arm_group_label>
      <arm_group_label>Abatacept Treatment B</arm_group_label>
      <other_name>Orencia®</other_name>
      <other_name>BMS-188667</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy participants, defined as having no clinically significant deviation from&#xD;
               normal in medical history; physical examinations that would compromise the ability to&#xD;
               participate, complete, and/or interpret the results of the study; 12-lead ECG; vital&#xD;
               signs; and clinical laboratory results&#xD;
  &#xD;
            -  Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening&#xD;
  &#xD;
            -  Participant must have a suitable injection site without tattoos, scarring, or other&#xD;
               conditions in the upper, outer arm that could interfere with SC administration&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Present malignancy or previous malignancy within the last 5 years prior to screening&#xD;
  &#xD;
            -  At risk for tuberculosis&#xD;
  &#xD;
            -  Any chronic bacterial infection within the previous 12 weeks of dosing&#xD;
  &#xD;
          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>Bristol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain NCT # and Site #.</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Local Institution</name>
        <address>
          <city>Cypress</city>
          <state>California</state>
          <zip>90630</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0003</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33147</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0002</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89113</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0001</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <link>
      <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>Investigator Inquiry Form</description>
    </link>
    <link>
      <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Abatacept</keyword>
    <keyword>Orencia</keyword>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Bioavailability</keyword>
    <keyword>BMS-188667</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abatacept</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html</ipd_description>
    </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/NCT05981976
  org study id: IM101-920
  nct id: NCT05981976
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to compare the relative absorption of abatacept in healthy
        participants following subcutaneous (SC) administration in which the drug substance is
        manufactured with the current or new process.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum observed serum concentration (Cmax)
  time frame: Up to Day 71
  measure: Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
  time frame: Up to Day 71
  measure: Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
  time frame: Up to Day 71
  measure: Number of participants with adverse events (AEs)
  time frame: Up to Month 12
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to Month 12
  measure: Number of participants with vital sign abnormalities
  time frame: Up to Month 12
  measure: Number of participants with electrocardiogram (ECG) abnormalities
  time frame: Up to Day 71
  measure: Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
  time frame: Up to Day 71
  measure: Serum concentration at 168 hours after dosing (C168)
  time frame: Up to Day 71
  measure: Time of maximum observed serum concentration (Tmax)
  time frame: Up to Day 71
  measure: Number of laboratory-reported positive responses of anti-abatacept antibodies
  time frame: Up to Month 12
  measure: Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
  time frame: Up to Day 71
  arm group label: Abatacept Treatment A
  arm group type: Experimental
  arm group label: Abatacept Treatment B
  arm group type: Experimental
  intervention type: Biological
  intervention name: Abatacept
  description: Specified dose on specified days
  arm group label: Abatacept Treatment A
  arm group label: Abatacept Treatment B
  other name: Orencia®
  other name: BMS-188667
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain NCT # and Site #.
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: https://www.bmsstudyconnect.com/s/US/English/USenHome
  description: BMS Clinical Trial Patient Recruiting
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: Investigator Inquiry Form
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  responsible party type: Sponsor
  mesh term: Abatacept
  sharing ipd: No
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html