NCT01029158

A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model

Conditions

• Scar Improvement

Interventions

Type	Name	Description
DRUG	Juvista (Avotermin)	250 ng, twice, intradermal injection, standard formulation
DRUG	RN1006 (Avotermin)	250 ng, intradermal injection, twice
DRUG	RN1006 (Avotermin)	205 ng, Intradermal injection, once
DRUG	RN1006 (Avotermin)	500ng, intradermal injection, once
DRUG	Juvista (Avotermin)	250 ng, intradermal injection, twice
DRUG	Juvista (Avotermin)	500 ng, intradermal injection, once
DRUG	Juvista (Avotermin)	500 ng, intradermal injection, once
DRUG	RN1006 (Avotermin)	500 ng, intradermal injection, twice
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-12-09
• Last updated: 2010-12-09

Locations

1 site across 1 country: United Kingdom