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Arthritis, RheumatoidPhase 1NCT03241446

Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)

A Phase 1 study testing Tilmanocept in people with Arthritis, Rheumatoid, run by Navidea Biopharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Tilmanocept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2017to Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
  • The subject is 30 - 65 years of age at the time of consent.
  • Has a negative urine drug screening for illicit or unprescribed drugs suggestive of drug abuse.
  • Subjects will have a BMI of 18 to 34 kg/m2, inclusive, at Screening
  • The subject has active RA as determined by the Clinical Disease Activity Index score of ≥ 10 and have ≥ 2 swollen joints.
  • If the subject is receiving methotrexate, they have been at a stable dose for > 4 weeks prior to the Day 1 visit.
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  • If the subject is receiving biologic therapy or other DMARDs, they have been at a stable dose > 8 weeks prior to the Day 1 visit.
  • If the subject is receiving NSAIDS or oral corticosteroids, the dose has been at a stable dose for > 4 weeks prior to the Day 1 visit. The corticosteroid dose should be ≤ 10mg/day of prednisone or an equivalent steroid dose.
  • Aside from being diagnosed with rheumatoid arthritis, subjects must be in good health, as determined by medical history, physical examination, vital sign assessment, 12 lead electrocardiogram (ECG) and clinical laboratory evaluations.

Who cannot join

  • The subject is pregnant or lactating.
  • The subject has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
  • The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator
  • The subject has a history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant
  • The subject has participated in a radiolabeled investigational study drug trial within 3 months prior to Day 1
  • The subject has exceeded yearly radioactive dose of 30 millisieverts (mSv)
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  • The subject has a history of drug abuse or alcohol within 2 years before dose administration, or positive drug or alcohol test at screening.
  • The subject has used tobacco- or nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Day 1, or positive cotinine screen
  • The subjects uses any prescription medications within 14 days prior to Day 1, except as allowed by the inclusion criteria or as deemed acceptable by the Investigator;
  • The subject uses any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/ herbal/plant-derived preparations) within 7 days prior to Day 1, unless deemed acceptable by the Investigator;
  • The subject has poor peripheral venous access;
  • The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks prior to Day 1
  • The subject has received blood products within 2 months prior to Day 1;
  • The subject has any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
  • The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

About this study

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

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.

Being tested
Tilmanocept
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TilmanoceptDrug

    Intravenously administered Technetium Tc 99m tilmanocept

Study groups in NCT03241446
Study groupRoleWhat they receive
50 ug TilmanoceptExperimentalSingle dose of 50 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
Receives: Drug: Tilmanocept
200 ug TilmanoceptExperimentalSingle dose of 200 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
Receives: Drug: Tilmanocept
400 ug TilmanoceptExperimentalSingle dose of 400 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m
Receives: Drug: Tilmanocept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept

    Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept

    Measured: 1 Days

  2. Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept

    Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept

    Measured: 2 Days

  3. Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept

    Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept

    Measured: 3 Days

  4. Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept

    Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept

    Measured: 2 days

  5. Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept

    Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept

    Measured: 3 days

  6. Clinical Dosimetry of Technetium Tc 99m Tilmanocept

    Clinical Dosimetry of Technetium Tc 99m Tilmanocept

    Measured: 3 days

Secondary outcomes (1)

  1. Incidence of Adverse Events

    Incidence of Adverse Events

    Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study startSep 2017 (estimated)
  3. Primary completionJan 2018 (estimated)
  4. Study completionMar 2018 (estimated)

Why it stopped: This study was combined with another trial that was on-going.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241446
Sponsor's protocol ID
NAV3-26
Status last verified
Oct 2018
First submitted
25 Jul 2017
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tilmanocept in people with Arthritis, Rheumatoid, run by Navidea Biopharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept (time frame: 1 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03241446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.

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