<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/NCT03241264</url>
  </required_header>
  <id_info>
    <org_study_id>ND-L02-s0201-004</org_study_id>
    <nct_id>NCT03241264</nct_id>
  </id_info>
  <brief_title>A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body</brief_title>
  <official_title>A Phase 1, Open-Label, Randomized-Sequence, Single-Crossover, Bridging Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Two ND-L02-s0201 Formulations, Frozen Versus Lyophilized, Administered by Intravenous Infusion to Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nitto Denko Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 evaluate the safety, tolerability, and the effects two&#xD;
      ND-L02-s0201 have on the body&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2016</start_date>
  <completion_date type="Actual">October 21, 2016</completion_date>
  <primary_completion_date type="Actual">October 21, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum plasma concentration (Tmax)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent first-order terminal elimination rate constant (Kel)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution during the elimination phase after IV administration (Vz)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution at steady-state (Vss)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total plasma clearance of drug after IV administration (CL/F)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent first-order terminal elimination half-life (T1/2)</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (SAEs)</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of discontinuations of study drug due to toxicity</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Fibrosis</condition>
  <arm_group>
    <arm_group_label>Module A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lyophilized Formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Module B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Frozen Formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ND-L02-s0201</intervention_name>
    <description>Specified dose on specified day</description>
    <arm_group_label>Module A</arm_group_label>
    <arm_group_label>Module B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is in good health, as determined by the Investigator&#xD;
&#xD;
          -  Subject consumes an average of no more than 2 alcoholic drinks per day within the 6&#xD;
             months before administration of study drug&#xD;
&#xD;
          -  Subject has serum calcium and parathyroid hormone (intact) within the limits of the&#xD;
             normal range of the laboratory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a disease or condition (medical or surgical) which, in the opinion of the&#xD;
             Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal,&#xD;
             gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions&#xD;
             that may interfere with the absorption, distribution, metabolism, or excretion of&#xD;
             ND-L02-s0201 solution, or that may place the subject at increased risk&#xD;
&#xD;
          -  Subject has a history of bone disease, including osteoporosis and osteomalacia,&#xD;
             Paget's disease of bone, or a history of unexplained fractures or fractures after&#xD;
             minimal trauma&#xD;
&#xD;
          -  Subject has abnormal laboratory values considered to be clinically significant by the&#xD;
             Investigator&#xD;
&#xD;
        Other protocol inclusion/exclusion criteria may 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>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</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>Fibrosis</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/NCT03241264
org study id: ND-L02-s0201-004
nct id: NCT03241264
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability, and the effects two
      ND-L02-s0201 have on the body
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax)
time frame: Up to 28 days
measure: Time to maximum plasma concentration (Tmax)
time frame: Up to 28 days
measure: Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
time frame: Up to 28 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
time frame: Up to 28 days
measure: Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
time frame: Up to 28 days
measure: Apparent first-order terminal elimination rate constant (Kel)
time frame: Up to 28 days
measure: Volume of distribution during the elimination phase after IV administration (Vz)
time frame: Up to 28 days
measure: Apparent volume of distribution at steady-state (Vss)
time frame: Up to 28 days
measure: Total plasma clearance of drug after IV administration (CL/F)
time frame: Up to 28 days
measure: Apparent first-order terminal elimination half-life (T1/2)
time frame: Up to 28 days
measure: Incidence of adverse events (AEs)
time frame: Up to 28 days
measure: Incidence of serious adverse events (SAEs)
time frame: Up to 28 days
measure: Incidence of discontinuations of study drug due to toxicity
time frame: Up to 28 days
arm group label: Module A
arm group type: Experimental
description: Lyophilized Formulation
arm group label: Module B
arm group type: Experimental
description: Frozen Formulation
intervention type: Drug
intervention name: ND-L02-s0201
description: Specified dose on specified day
arm group label: Module A
arm group label: Module B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Fibrosis