Investigation of the Safety, Dosing Frequency and Anti-Scarring Potential of Two Concentrations of Intradermal Avotermin (Juvista)

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations of intradermal RN1001 in healthy male subjects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renovo

Criteria

Inclusion Criteria:

• Healthy, non-Caribbean, male subjects aged 18-45 years inclusive

• Weight between 60-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-45 kg/m(squared)) (weight (kg)/height (squared)(m))

• Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation

Exclusion Criteria:

• Subjects who have a history or evidence of hypertrophic or keloid scarring

• Subjects with tattoos or previous scars in the area to be biopsied

• Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders