drugset

drugset / Trial / NCT01730417

Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG

NCT01730417 ↗

Phase 1 Completed 12 enrolled Bennett Chin Molecular Insights Pharmaceuticals · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelDiagnostic

Summary

The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers.

Timeline

Start: 2009-11
Primary completion: 2011-06
Completion: 2011-07

Publications

Results Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765-71. doi: 10.2967/jnumed.113.124057. Epub 2014 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MIBG	Other / unclassified	—	—

Indications