<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/NCT03241446</url>
  </required_header>
  <id_info>
    <org_study_id>NAV3-26</org_study_id>
    <nct_id>NCT03241446</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)</brief_title>
  <official_title>A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navidea Biopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Navidea Biopharmaceuticals</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>
      A prospective, open-label, single center, study to evaluate pharmacokinetics and dosimetry of&#xD;
      intravenously injected Tc 99m tilmanocept at three mass doses (50 µg, 200 µg, and 400 µg)&#xD;
      radiolabeled with 10 millicuries (mCi) Tc 99m.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study was combined with another trial that was on-going.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>1 Days</time_frame>
    <description>Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>2 Days</time_frame>
    <description>Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>3 Days</time_frame>
    <description>Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>2 days</time_frame>
    <description>Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>3 days</time_frame>
    <description>Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Dosimetry of Technetium Tc 99m Tilmanocept</measure>
    <time_frame>3 days</time_frame>
    <description>Clinical Dosimetry of Technetium Tc 99m Tilmanocept</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>7 Days</time_frame>
    <description>Incidence of Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>50 ug Tilmanocept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 50 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 ug Tilmanocept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 200 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 ug Tilmanocept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 400 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tilmanocept</intervention_name>
    <description>Intravenously administered Technetium Tc 99m tilmanocept</description>
    <arm_group_label>200 ug Tilmanocept</arm_group_label>
    <arm_group_label>400 ug Tilmanocept</arm_group_label>
    <arm_group_label>50 ug Tilmanocept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject has provided written informed consent with HIPAA (Health Information&#xD;
             Portability and Accountability Act) authorization before the initiation of any&#xD;
             study-related procedures.&#xD;
&#xD;
          2. The subject is 30 - 65 years of age at the time of consent.&#xD;
&#xD;
          3. Has a negative urine drug screening for illicit or unprescribed drugs suggestive of&#xD;
             drug abuse.&#xD;
&#xD;
          4. Subjects will have a BMI of 18 to 34 kg/m2, inclusive, at Screening&#xD;
&#xD;
          5. The subject has active RA as determined by the Clinical Disease Activity Index score&#xD;
             of ≥ 10 and have ≥ 2 swollen joints.&#xD;
&#xD;
          6. If the subject is receiving methotrexate, they have been at a stable dose for &gt; 4&#xD;
             weeks prior to the Day 1 visit.&#xD;
&#xD;
          7. If the subject is receiving biologic therapy or other DMARDs, they have been at a&#xD;
             stable dose &gt; 8 weeks prior to the Day 1 visit.&#xD;
&#xD;
          8. If the subject is receiving NSAIDS or oral corticosteroids, the dose has been at a&#xD;
             stable dose for &gt; 4 weeks prior to the Day 1 visit. The corticosteroid dose should be&#xD;
             ≤ 10mg/day of prednisone or an equivalent steroid dose.&#xD;
&#xD;
          9. Aside from being diagnosed with rheumatoid arthritis, subjects must be in good health,&#xD;
             as determined by medical history, physical examination, vital sign assessment, 12 lead&#xD;
             electrocardiogram (ECG) and clinical laboratory evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is pregnant or lactating.&#xD;
&#xD;
          2. The subject has a significant history or clinical manifestation of any metabolic,&#xD;
             allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, or psychiatric disorder (as determined by the&#xD;
             Investigator)&#xD;
&#xD;
          3. The subject has a history of significant hypersensitivity, intolerance, or allergy to&#xD;
             dextran or modified forms of dextran; unless approved by the Investigator&#xD;
&#xD;
          4. The subject has a history or presence of an abnormal ECG, which, in the Investigator's&#xD;
             opinion, is clinically significant&#xD;
&#xD;
          5. The subject has participated in a radiolabeled investigational study drug trial within&#xD;
             3 months prior to Day 1&#xD;
&#xD;
          6. The subject has exceeded yearly radioactive dose of 30 millisieverts (mSv)&#xD;
&#xD;
          7. The subject has a history of drug abuse or alcohol within 2 years before dose&#xD;
             administration, or positive drug or alcohol test at screening.&#xD;
&#xD;
          8. The subject has used tobacco- or nicotine-containing products (including but not&#xD;
             limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches,&#xD;
             nicotine lozenges, or nicotine gum) within 6 months prior to Day 1, or positive&#xD;
             cotinine screen&#xD;
&#xD;
          9. The subjects uses any prescription medications within 14 days prior to Day 1, except&#xD;
             as allowed by the inclusion criteria or as deemed acceptable by the Investigator;&#xD;
&#xD;
         10. The subject uses any over-the-counter, non-prescription preparations (including&#xD;
             vitamins, minerals, and phytotherapeutic/ herbal/plant-derived preparations) within 7&#xD;
             days prior to Day 1, unless deemed acceptable by the Investigator;&#xD;
&#xD;
         11. The subject has poor peripheral venous access;&#xD;
&#xD;
         12. The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks&#xD;
             prior to Day 1&#xD;
&#xD;
         13. The subject has received blood products within 2 months prior to Day 1;&#xD;
&#xD;
         14. The subject has any acute or chronic condition that, in the opinion of the&#xD;
             Investigator, would limit the subject's ability to complete and/or participate in this&#xD;
             clinical study.&#xD;
&#xD;
         15. The subject has received any radiopharmaceutical within 7 days prior to the&#xD;
             administration of Tc 99m tilmanocept.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_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/NCT03241446
org study id: NAV3-26
nct id: NCT03241446
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A prospective, open-label, single center, study to evaluate pharmacokinetics and dosimetry of
      intravenously injected Tc 99m tilmanocept at three mass doses (50 µg, 200 µg, and 400 µg)
      radiolabeled with 10 millicuries (mCi) Tc 99m.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept
time frame: 1 Days
description: Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept
measure: Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept
time frame: 2 Days
description: Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept
measure: Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept
time frame: 3 Days
description: Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept
measure: Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept
time frame: 2 days
description: Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept
measure: Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept
time frame: 3 days
description: Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept
measure: Clinical Dosimetry of Technetium Tc 99m Tilmanocept
time frame: 3 days
description: Clinical Dosimetry of Technetium Tc 99m Tilmanocept
measure: Incidence of Adverse Events
time frame: 7 Days
description: Incidence of Adverse Events
arm group label: 50 ug Tilmanocept
arm group type: Experimental
description: Single dose of 50 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
arm group label: 200 ug Tilmanocept
arm group type: Experimental
description: Single dose of 200 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
arm group label: 400 ug Tilmanocept
arm group type: Experimental
description: Single dose of 400 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
intervention type: Drug
intervention name: Tilmanocept
description: Intravenously administered Technetium Tc 99m tilmanocept
arm group label: 200 ug Tilmanocept
arm group label: 400 ug Tilmanocept
arm group label: 50 ug Tilmanocept
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No