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/NCT05995691</url>
    </required_header>
    <id_info>
      <org_study_id>20120176</org_study_id>
      <nct_id>NCT05995691</nct_id>
    </id_info>
    <brief_title>Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants</brief_title>
    <official_title>A Randomized, Single-blind, Single-dose, 2-Arm, Parallel-group Study to Determine the Pharmacokinetic Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amgen</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amgen</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 primary objective of this study is to determine the bioequivalence of ABP 501&#xD;
        (subcutaneous [SC] injection) compared to adalimumab (SC injection) as assessed principally&#xD;
        by the area under the serum concentration-time curve from time 0 extrapolated to infinity&#xD;
        (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 24, 2014</start_date>
    <completion_date type="Actual">December 4, 2015</completion_date>
    <primary_completion_date type="Actual">December 4, 2015</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>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AUCinf of ABP 501</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax of ABP 501</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUCinf of Adalimumab</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax of Adalimumab</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>Day 1 to Day 63</time_frame>
      <description>Any clinically significant changes in vital signs or clinical laboratory test results after the dose of treatment will be recorded as TEAEs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Anti-drug Antibodies (ADA)</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal Phase Elimination Half-life (t1/2) of ABP 501</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2 of Adalimumab</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of Adalimumab</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUClast of Adalimumab</measure>
      <time_frame>Day 1 to Day 63</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">179</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>ABP 501</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of ABP 501</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adalimumab</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive a single dose of adalimumab</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ABP 501</intervention_name>
      <description>SC injection</description>
      <arm_group_label>ABP 501</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Adalimumab</intervention_name>
      <description>SC injection</description>
      <arm_group_label>Adalimumab</arm_group_label>
      <other_name>Humira®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            1. Participants must sign an Institutional Review Board (IRB)/Independent Ethics&#xD;
               Committee (IEC) approved ICF before any study-specific procedures are performed.&#xD;
  &#xD;
            2. Healthy adult male and female Japanese participants between 18 and 45 years of age,&#xD;
               inclusive, at the time of screening.&#xD;
  &#xD;
            3. Body mass index (BMI) between 16.0 and 25.0 kg/m2, inclusive, at screening and Day -1.&#xD;
  &#xD;
            4. Normal or clinically acceptable physical examination, clinical laboratory test values,&#xD;
               vital signs, and electrocardiogram (ECG) (12-lead ECG reporting heart rate and RR, PR,&#xD;
               QRS, QT, and QTc intervals), as determined by the investigator, at screening. Physical&#xD;
               examination, vital signs, body weight and BMI, clinical laboratory tests, pregnancy&#xD;
               test, urinalysis, urine drug screen, and alcohol screen will be repeated on Day -1&#xD;
               (see Table 2-1) and must also be normal or clinically acceptable, as deemed by the&#xD;
               investigator.&#xD;
  &#xD;
            5. Participants must be current on immunizations per local standards.&#xD;
  &#xD;
            6. Participants must be first- or second-generation Japanese:&#xD;
  &#xD;
                 -  First-generation Japanese are participants who may be living outside of Japan but&#xD;
                    were born in Japan to parents of Japanese descent&#xD;
  &#xD;
                 -  Second-generation Japanese are participants who were born outside of Japan to&#xD;
                    first-generation Japanese parents&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            1. Women of childbearing potential who are unwilling to practice a highly effective&#xD;
               method of birth control for the duration of the study and for 5 months following&#xD;
               treatment with the investigational product or until the scheduled end-of-study (EOS)&#xD;
               (whichever is longer). Acceptable methods of effective birth control include:&#xD;
  &#xD;
                 -  Abstinence&#xD;
  &#xD;
                 -  Surgical methods: bilateral tubal ligation or vasectomy for the male sexual&#xD;
                    partner&#xD;
  &#xD;
                 -  Hormonal methods&#xD;
  &#xD;
                 -  Intrauterine device (IUD)&#xD;
  &#xD;
                 -  Two barrier methods (one by each partner)&#xD;
  &#xD;
                      -  The male must use a condom (latex or other synthetic material)&#xD;
  &#xD;
                      -  The female may select one of the following barrier methods: diaphragm,&#xD;
                         cervical, or contraceptive sponge&#xD;
  &#xD;
            2. Women who are lactating or breastfeeding.&#xD;
  &#xD;
            3. Women with a positive pregnancy test.&#xD;
  &#xD;
            4. Women planning to become pregnant during the study or within 5 months following&#xD;
               treatment with investigational product.&#xD;
  &#xD;
            5. History or evidence of a clinically significant disorder (including psychiatric),&#xD;
               condition, or disease that, in the opinion of the investigator, would pose a risk to&#xD;
               participant safety or interfere with the study evaluation, procedures, or completion.&#xD;
  &#xD;
            6. History or evidence of any bacterial, viral, parasitic, or systemic fungal infections&#xD;
               within the past 30 days prior to investigational product administration (eg, upper&#xD;
               respiratory tract infection, viral syndrome, flu-like symptoms). Exception: a simple,&#xD;
               short-duration common cold within the past 14 days prior to investigational product&#xD;
               administration.&#xD;
  &#xD;
            7. A recent infection (within 6 months of randomization) requiring inpatient&#xD;
               hospitalization or intravenous antibiotics.&#xD;
  &#xD;
            8. Known positive tuberculin skin test or exposure to an individual with tuberculosis&#xD;
               (TB) or positive QuantiFERON® test or local equivalent (eg, T-Spot®) consistent with&#xD;
               previous exposure to TB prior to or during screening (if not treated with appropriate&#xD;
               chemoprophylaxis).&#xD;
  &#xD;
            9. Tuberculosis or fungal infection seen on available chest x-ray taken within 6 months&#xD;
               of screening or at screening.&#xD;
  &#xD;
           10. History of malignancy of any type, other than surgically excised nonmelanomatous skin&#xD;
               cancers, within 5 years prior to randomization.&#xD;
  &#xD;
           11. Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface&#xD;
               antigen (HBsAg), or hepatitis C virus (HCV) at screening.&#xD;
  &#xD;
           12. Positive screen for alcohol and/or potential drugs of abuse at screening or prior to&#xD;
               randomization.&#xD;
  &#xD;
           13. Receiving or has received any investigational drug (or is currently using an&#xD;
               investigational device) within 30 days or 5 half-lives (whichever is longer), prior to&#xD;
               receiving investigational product.&#xD;
  &#xD;
           14. Use of any over-the-counter (OTC) or prescription medications within the 14 days or 5&#xD;
               half-lives (whichever is longer), prior to receiving investigational product.&#xD;
               Acetaminophen (up to 2 g per day and not more than 4 g per week) for analgesia will be&#xD;
               allowed. Hormonal contraceptives are allowed.&#xD;
  &#xD;
           15. All herbal medicines (eg, St. John's wort) and supplements consumed by the participant&#xD;
               within the 30 days prior to receiving investigational product, and continuing use if&#xD;
               applicable, will be reviewed by the investigator and the ICON medical monitor. Written&#xD;
               documentation of this review and Amgen acknowledgment of the decision made with&#xD;
               respect to eligibility is required for participant participation.&#xD;
  &#xD;
           16. Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within&#xD;
               2 months of screening.&#xD;
  &#xD;
           17. Received live vaccines ≤ 3 months prior to investigational product administration or&#xD;
               are scheduled to receive a live vaccine within 3 months following treatment with&#xD;
               investigational product.&#xD;
  &#xD;
           18. Known or suspected sensitivity to products derived from mammalian cell lines.&#xD;
  &#xD;
           19. Known allergy to natural rubber (latex).&#xD;
  &#xD;
           20. Previously received adalimumab or a biosimilar of adalimumab.&#xD;
  &#xD;
           21. History of alcohol and/or substance abuse within the last 12 months from screening.&#xD;
  &#xD;
           22. Participants who use &gt; 10 cigarettes per day within the last 3 months or not able to&#xD;
               abide by the smoking policy of the clinical pharmacology unit (CPU).&#xD;
  &#xD;
           23. Inability or unwillingness to reside at the CPU for 2 consecutive days or inability to&#xD;
               be available for follow-up assessments or protocol-required procedures.&#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_official>
      <last_name>MD</last_name>
      <role>Study Director</role>
      <affiliation>Amgen</affiliation>
    </overall_official>
    <link>
      <url>http://www.amgentrials.com</url>
      <description>AmgenTrials clinical trials website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ABP 501</keyword>
    <keyword>Adalimumab</keyword>
    <keyword>Humira®</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adalimumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</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_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
      <ipd_url>http://www.amgen.com/datasharing</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/NCT05995691
  org study id: 20120176
  nct id: NCT05995691
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to determine the bioequivalence of ABP 501
        (subcutaneous [SC] injection) compared to adalimumab (SC injection) as assessed principally
        by the area under the serum concentration-time curve from time 0 extrapolated to infinity
        (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: AUCinf of ABP 501
  time frame: Day 1 to Day 63
  measure: Cmax of ABP 501
  time frame: Day 1 to Day 63
  measure: AUCinf of Adalimumab
  time frame: Day 1 to Day 63
  measure: Cmax of Adalimumab
  time frame: Day 1 to Day 63
  measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
  time frame: Day 1 to Day 63
  description: Any clinically significant changes in vital signs or clinical laboratory test results after the dose of treatment will be recorded as TEAEs.
  measure: Number of Participants With Anti-drug Antibodies (ADA)
  time frame: Day 1 to Day 63
  measure: Terminal Phase Elimination Half-life (t1/2) of ABP 501
  time frame: Day 1 to Day 63
  measure: t1/2 of Adalimumab
  time frame: Day 1 to Day 63
  measure: Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501
  time frame: Day 1 to Day 63
  measure: Tmax of Adalimumab
  time frame: Day 1 to Day 63
  measure: Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501
  time frame: Day 1 to Day 63
  measure: AUClast of Adalimumab
  time frame: Day 1 to Day 63
  arm group label: ABP 501
  arm group type: Experimental
  description: Participants will receive a single dose of ABP 501
  arm group label: Adalimumab
  arm group type: Active Comparator
  description: Participants will receive a single dose of adalimumab
  intervention type: Drug
  intervention name: ABP 501
  description: SC injection
  arm group label: ABP 501
  intervention type: Drug
  intervention name: Adalimumab
  description: SC injection
  arm group label: Adalimumab
  other name: Humira®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MD
  role: Study Director
  affiliation: Amgen
  url: http://www.amgentrials.com
  description: AmgenTrials clinical trials website
  responsible party type: Sponsor
  mesh term: Adalimumab
  sharing ipd: Yes
  ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
  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 time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
  ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
  ipd url: http://www.amgen.com/datasharing