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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03241446
• Date of registration: 25/07/2017
• Prospective Registration: Yes
• Primary sponsor: Navidea Biopharmaceuticals
• Public title: Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
• Scientific 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
• Date of first enrolment: September 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03241446
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The subject has provided written informed consent with HIPAA (Health Information
Portability and Accountability Act) authorization before the initiation of any
study-related procedures.

2. The subject is 30 - 65 years of age at the time of consent.

3. Has a negative urine drug screening for illicit or unprescribed drugs suggestive of
drug abuse.

4. Subjects will have a BMI of 18 to 34 kg/m2, inclusive, at Screening

5. The subject has active RA as determined by the Clinical Disease Activity Index score
of = 10 and have = 2 swollen joints.

6. If the subject is receiving methotrexate, they have been at a stable dose for > 4
weeks prior to the Day 1 visit.

7. 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.

8. 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.

9. 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.

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. 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)

3. The subject has a history of significant hypersensitivity, intolerance, or allergy to
dextran or modified forms of dextran; unless approved by the Investigator

4. The subject has a history or presence of an abnormal ECG, which, in the Investigator's
opinion, is clinically significant

5. The subject has participated in a radiolabeled investigational study drug trial within
3 months prior to Day 1

6. The subject has exceeded yearly radioactive dose of 30 millisieverts (mSv)

7. The subject has a history of drug abuse or alcohol within 2 years before dose
administration, or positive drug or alcohol test at screening.

8. 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

9. 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;

10. 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;

11. The subject has poor peripheral venous access;

12. The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks
prior to Day 1

13. The subject has received blood products within 2 months prior to Day 1;

14. 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.

15. The subject has received any radiopharmaceutical within 7 days prior to the
administration of Tc 99m tilmanocept.



Age minimum: 30 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Tilmanocept

Primary Outcome(s)

Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept [Time Frame: 2 Days]

Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept [Time Frame: 1 Days]

Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept [Time Frame: 2 days]

Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept [Time Frame: 3 days]

Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept [Time Frame: 3 Days]

Clinical Dosimetry of Technetium Tc 99m Tilmanocept [Time Frame: 3 days]

Secondary Outcome(s)

Incidence of Adverse Events [Time Frame: 7 Days]

Secondary ID(s)

NAV3-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors