Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess
safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream,
administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the
Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical
application. After a 24h washout time break, the subject will enter the treatment period for
5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of
treatment.