drugset / Trial / NCT02284360
A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
RandomizedParallel-groupDouble-blind
Summary
This is a prospective, single center, randomized, double-blinded, placebo-controlled, exploratory phase I clinical trial in healthy male subjects to investigate the safety and tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound healing of APOSEC™.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-06
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APOSEC™ | Protein / enzyme biologic | 1.25e+07 unknown | Topical |
| Subject | APOSEC™ | Protein / enzyme biologic | 2.5e+07 unknown | Topical |
Indications
No indication recorded.