NCT01863160

Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Shulov Innovate for Science Ltd. 2012 · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary endpoints of this study are: * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score. * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events. * Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers. The secondary endpoints of this study are: * Systemic absorption PK profile. * Dermal absorption PK profile (Optional). Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables: * Dermal reaction parameters * Physical examination * Vital Signs (HR, BP, RR, Body temperature) * 12 lead ECG data * Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis) * Adverse events recording * Change in concomitant medications

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	0.1% ZEP-3 cream	Topical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area. * Right arm, single treatment area - ZEP-3 (0.1%) * Left arm, single treatment area - Placebo cream
DRUG	placebo	Topical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area. Right arm, single treatment area - ZEP-3 (1.0%) Left arm, single treatment area - Placebo cream

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2013-05-27
• Last updated: 2014-02-20

Locations

1 site across 1 country: Israel