drugset / Trial / NCT03241446

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

NCT03241446 ↗

Phase 1 Withdrawn Navidea Biopharmaceuticals
Non-randomizedSequentialOpen-labelDiagnostic

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.

Timeline

Start
2017-09
Primary completion
2018-01
Completion
2018-03

Outcome

Outcome not reported

Stopped: “This study was combined with another trial that was on-going.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tilmanocept Diagnostic / imaging agent 50 ug Intravenous
Subject Tilmanocept Diagnostic / imaging agent 200 ug Intravenous
Subject Tilmanocept Diagnostic / imaging agent 400 ug Intravenous

Indications