<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/NCT03794180</url>
  </required_header>
  <id_info>
    <org_study_id>TJ003234RAR101</org_study_id>
    <nct_id>NCT03794180</nct_id>
  </id_info>
  <brief_title>Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects</brief_title>
  <official_title>First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I-Mab Biopharma Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I-Mab Biopharma Co. Ltd.</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>
      TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind,&#xD;
      placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine&#xD;
      whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and&#xD;
      to determine the maximum dose tolerated (MTD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Profile: AEs</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Incidence of Adverse Events (AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Determine Maximum Tolerated Dose of TJ003234</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameters: Tmax</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Time of peak concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameters: Cmax</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Maximal Concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameters: T1/2</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Investigational product (IP) half-life (T1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameters: CL</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Investigational Product (IP) Clearance (CL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameters: AUC∞</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Area under the curve from time zero extrapolated to infinity (AUC∞)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-drug antibodies (ADA)</measure>
    <time_frame>Up to 85 days after study drug administration</time_frame>
    <description>Incidence and concentration of anti-drug antibodies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Adult Subjects</condition>
  <arm_group>
    <arm_group_label>TJ003234</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 mg/kg via single IV infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TJ003234</intervention_name>
    <description>Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline</description>
    <arm_group_label>TJ003234</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and willing to sign the informed consent form (ICF)&#xD;
&#xD;
          -  Healthy subjects 18-70 years of age&#xD;
&#xD;
          -  If of childbearing potential, agree to use protocol-specified contraception&#xD;
&#xD;
          -  Body mass index (BMI) 19.0-32.0 kg/m^2&#xD;
&#xD;
          -  Blood pressure ≤ 139/89 mm Hg&#xD;
&#xD;
          -  Subjects are able to follow the study protocol and complete the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of tobacco or nicotine-containing products or illicit drug use&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reaction to a therapeutic drug or severe&#xD;
             seasonal allergies&#xD;
&#xD;
          -  Any known pulmonary disease&#xD;
&#xD;
          -  Use of any prescription, investigational drugs, herbal supplements, or nonprescription&#xD;
             drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug&#xD;
             administration, or dietary supplements within 1 week prior to study drug&#xD;
             administration, unless, in the opinion of the Investigator and Sponsor, the medication&#xD;
             will not interfere with the study&#xD;
&#xD;
          -  Abnormal hematological and chemistry laboratory values &gt;10% above upper limit of&#xD;
             normal (ULN) or &gt;10% below the lower limit of normal (LLN). Absolute neutrophil count&#xD;
             (ANC) ≤ 1000 cells/mm^3&#xD;
&#xD;
          -  Use of any biologic drugs in the last 120 days prior to dosing.&#xD;
&#xD;
          -  Immunization with a live or attenuated vaccine within 4 weeks prior to study drug&#xD;
             administration&#xD;
&#xD;
          -  Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists&#xD;
&#xD;
          -  ADA screening positive&#xD;
&#xD;
          -  Subjects who have a history of documented autoimmune disease, even if not clinically&#xD;
             severe or never treated with systemic steroids or immunosuppressive agents&#xD;
&#xD;
          -  A positive alcohol test and/or urine drug screen for substance of abuse at screening&#xD;
             or upon check-in to the clinical site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Xu, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>I-Mab Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmaron</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anti-GM-CSF agents</keyword>
  <keyword>GM-CSF/GM-CSFR (GM-CSF receptor) antibody</keyword>
  <keyword>colony-stimulating factor 2</keyword>
  <keyword>monoclonal antibody</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plonmarlimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03794180
org study id: TJ003234RAR101
nct id: NCT03794180
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind,
      placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine
      whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and
      to determine the maximum dose tolerated (MTD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Safety Profile: AEs
time frame: Up to 85 days after study drug administration
description: Incidence of Adverse Events (AEs)
measure: Maximum Tolerated Dose
time frame: Up to 85 days after study drug administration
description: Determine Maximum Tolerated Dose of TJ003234
measure: Pharmacokinetic (PK) Parameters: Tmax
time frame: Up to 85 days after study drug administration
description: Time of peak concentration (Tmax)
measure: Pharmacokinetic (PK) Parameters: Cmax
time frame: Up to 85 days after study drug administration
description: Maximal Concentration (Cmax)
measure: Pharmacokinetic (PK) Parameters: T1/2
time frame: Up to 85 days after study drug administration
description: Investigational product (IP) half-life (T1/2)
measure: Pharmacokinetic (PK) Parameters: CL
time frame: Up to 85 days after study drug administration
description: Investigational Product (IP) Clearance (CL)
measure: Pharmacokinetic (PK) Parameters: AUC∞
time frame: Up to 85 days after study drug administration
description: Area under the curve from time zero extrapolated to infinity (AUC∞)
measure: Anti-drug antibodies (ADA)
time frame: Up to 85 days after study drug administration
description: Incidence and concentration of anti-drug antibodies
arm group label: TJ003234
arm group type: Experimental
description: 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: 0 mg/kg via single IV infusion
intervention type: Drug
intervention name: TJ003234
description: Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
arm group label: TJ003234
intervention type: Drug
intervention name: Placebo
description: Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire Xu, MD, PhD
role: Study Director
affiliation: I-Mab Biopharma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Plonmarlimab
sharing ipd: No