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A Double Blind, Placebo (Vehicle) and Standard Care Controlled, Randomised, Parallel Group Study to Investigate the Clinical Safety, Toleration, Systemic Pharmacokinetics and Local Pharmacodynamics of Repeated, Escalating Concentrations of Intradermal RN1001 in Healthy Male Subjects.
The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.
Details
| Lead sponsor | Renovo |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 55 |
| Start date | 2001-05 |
| Completion | 2001-08 |
Conditions
- Cicatrix
- Wound Healing
Interventions
- Avotermin
- Avotermin
- Avotermin
- Avotermin
- Avotermin
- Avotermin
- Placebo (vehicle)
Primary outcomes
- To determine the safety and local toleration of various dose levels of avotermin (Juvista) injected intradermally into healthy male volunteers. — Days 0 and 1 and either 3 and 4 or 7 and 8 in addition to Day 10. A single post-trial follow-up was made between days 17-24.
Countries
United Kingdom