Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

Phase 1/2 Completed 103 enrolled Renovo

RandomizedParallel-groupQuadruple-blindBasic science

Summary

A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects

Timeline

Start: 2001-11
Primary completion: 2003-09
Completion: 2003-09

Publications

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avotermin	Protein / enzyme biologic	0.25 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	1 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	5 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	20 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	50 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	100 ng	Intravenous
Subject	Avotermin	Protein / enzyme biologic	500 ng	Intravenous

Indications

No indication recorded.