drugset
drugset / Trial / NCT02865434

Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

NCT02865434 ↗

Phase 1/2 Completed 39 enrolled Navidea Biopharmaceuticals
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.

Timeline

Start
2017-01
Primary completion
2018-06
Completion
2018-06

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
Subject Tilmanocept Diagnostic / imaging agent 37 mbq Intravenous
Subject Tilmanocept Diagnostic / imaging agent 185 mbq Intravenous
Subject Tilmanocept Diagnostic / imaging agent 370 mbq Intravenous

Indications

rheumatoid arthritis