Intra-Arterial Microdosing: Proof-of-Concept in Humans

Phase 0 Completed 10 enrolled Duke University

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this protocol is to demonstrate that intra-arterial administration of a drug can generate information in a manner that faithfully mimics effects of systemic administration but with little or no systemic effects.

Timeline

Start: 2014-12
Primary completion: 2015-07
Completion: 2015-07

Publications

Background Burt T, Rouse DC, Lee K, Wu H, Layton AT, Hawk TC, Weitzel DH, Chin BB, Cohen-Wolkowiez M, Chow SC, Noveck RJ. Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats. J Nucl Med. 2015 Nov;56(11):1793-9. doi: 10.2967/jnumed.115.160986. Epub 2015 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin	Protein / enzyme biologic	—	Other

Indications

No indication recorded.