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

NCT02284360 ↗

Phase 1 Completed 10 enrolled Medical University of Vienna
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

EvaluationDrugModalityDoseRoute
Subject APOSEC™ Protein / enzyme biologic 1.25e+07 unknown Topical
Subject APOSEC™ Protein / enzyme biologic 2.5e+07 unknown Topical

Indications

No indication recorded.