<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/NCT04446000</url>
  </required_header>
  <id_info>
    <org_study_id>CSL730_1002</org_study_id>
    <secondary_id>2019-001940-23</secondary_id>
    <nct_id>NCT04446000</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</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>
      This phase 1, randomized, double-blind, placebo-controlled study will assess the safety,&#xD;
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of&#xD;
      CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of clinical viability&#xD;
  </why_stopped>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">March 28, 2023</completion_date>
  <primary_completion_date type="Actual">March 28, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity</measure>
    <time_frame>Within 96 hours and up to 56 days after CSL730 administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of subjects with TEAEs overall, by causality, and by severity</measure>
    <time_frame>Within 96 hours and up to 56 days after CSL730 administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with localized administration site AEs overall, by causality, and by severity</measure>
    <time_frame>Within 96 hours and up to 56 days after CSL730 administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of subjects with localized administration site AEs overall, by causality, and by severity</measure>
    <time_frame>Within 96 hours and up to 56 days after CSL730 administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum concentration (Tmax) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half-life (T1/2) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total systemic clearance (CL/F) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples</measure>
    <time_frame>up to 56 days after CSL730 administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of anti-CSL730 antibodies detected in serum samples</measure>
    <time_frame>Days 15, 29, and 56</time_frame>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Immune Complex-mediated Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>CSL730 (dose 1 with premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by subcutaneous (SC) injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 2 with premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 3 with premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 1 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 2 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 3 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 4 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 5 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 6 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL730 (dose 7 without premedication)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CSL730</intervention_name>
    <description>solution for injection and infusion</description>
    <arm_group_label>CSL730 (dose 1 with premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 1 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 2 with premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 2 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 3 with premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 3 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 4 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 5 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 6 without premedication)</arm_group_label>
    <arm_group_label>CSL730 (dose 7 without premedication)</arm_group_label>
    <other_name>Recombinant trivalent human IgG1 Fc multimer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A solution matching the excipient profile of CSL730 without the active substance</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years&#xD;
&#xD;
          -  Females must be either postmenopausal or sterile&#xD;
&#xD;
          -  Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤&#xD;
             30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current evidence of a clinically significant medical condition, disorder,&#xD;
             or disease, including but not limited to any of the following: hepatic (hepatitis,&#xD;
             cirrhosis, or history of liver disease, drug reaction, or aminotransaminase&#xD;
             elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular;&#xD;
             hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid&#xD;
             disorders, adrenal disease); neurologic (including history of migraine); psychiatric;&#xD;
             immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer&#xD;
             [except melanoma] who have had no evidence of disease in the last 5 years are&#xD;
             eligible), that precludes designation of healthy subjects as judged by the&#xD;
             Investigator&#xD;
&#xD;
          -  History or evidence of congenital or acquired immunosuppressive condition(s),&#xD;
             including positive serology for human immunodeficiency virus infection or taking&#xD;
             immunosuppressive agents.&#xD;
&#xD;
          -  Evidence of active or latent tuberculosis&#xD;
&#xD;
          -  Hospitalization within 3 months before IP administration or planned hospitalization at&#xD;
             any time during the study.&#xD;
&#xD;
          -  History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to&#xD;
             latex or any drug product&#xD;
&#xD;
          -  A positive test result for drugs of abuse.&#xD;
&#xD;
          -  Smokers within 3 months before Screening.&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>CSL Behring</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital</name>
      <address>
        <city>Harrow</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.&#xD;
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.&#xD;
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.</ipd_time_frame>
    <ipd_access_criteria>Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.&#xD;
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.&#xD;
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.</ipd_access_criteria>
  </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/NCT04446000
org study id: CSL730_1002
secondary id: 2019-001940-23
nct id: NCT04446000
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase 1, randomized, double-blind, placebo-controlled study will assess the safety,
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of
      CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
time frame: Within 96 hours and up to 56 days after CSL730 administration
measure: Percent of subjects with TEAEs overall, by causality, and by severity
time frame: Within 96 hours and up to 56 days after CSL730 administration
measure: Number of subjects with localized administration site AEs overall, by causality, and by severity
time frame: Within 96 hours and up to 56 days after CSL730 administration
measure: Percent of subjects with localized administration site AEs overall, by causality, and by severity
time frame: Within 96 hours and up to 56 days after CSL730 administration
measure: Maximum concentration (Cmax) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Time of maximum concentration (Tmax) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Terminal elimination half-life (T1/2) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Apparent total systemic clearance (CL/F) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples
time frame: up to 56 days after CSL730 administration
measure: Levels of anti-CSL730 antibodies detected in serum samples
time frame: Days 15, 29, and 56
arm group label: CSL730 (dose 1 with premedication)
arm group type: Experimental
description: administered as a single dose by subcutaneous (SC) injection or by SC infusion
arm group label: CSL730 (dose 2 with premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 3 with premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 1 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 2 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 3 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 4 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 5 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 6 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: CSL730 (dose 7 without premedication)
arm group type: Experimental
description: administered as a single dose by SC injection or by SC infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion
intervention type: Biological
intervention name: CSL730
description: solution for injection and infusion
arm group label: CSL730 (dose 1 with premedication)
arm group label: CSL730 (dose 1 without premedication)
arm group label: CSL730 (dose 2 with premedication)
arm group label: CSL730 (dose 2 without premedication)
arm group label: CSL730 (dose 3 with premedication)
arm group label: CSL730 (dose 3 without premedication)
arm group label: CSL730 (dose 4 without premedication)
arm group label: CSL730 (dose 5 without premedication)
arm group label: CSL730 (dose 6 without premedication)
arm group label: CSL730 (dose 7 without premedication)
other name: Recombinant trivalent human IgG1 Fc multimer
intervention type: Drug
intervention name: Placebo
description: A solution matching the excipient profile of CSL730 without the active substance
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: CSL Behring
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Autoimmune Diseases
sharing ipd: Yes
ipd description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
ipd access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.