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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863160
• Other study ID #: ZEP - 001 - IL
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2013
• Last updated: February 19, 2014
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: August 2013
• Source: Shulov Innovate for Science Ltd. 2012
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures

2. Subject, either men or women is between 18 and 50 years of age.

3. Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)

4. Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article

5. Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.

6. Subject is willing to participate in the study and adhere to the study protocol

7. Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.

Exclusion Criteria:

1. Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields

2. Dark skinned persons whose skin color prevents ready assessment of skin reactions

3. Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea

4. UV therapy or significant UV exposure in the four weeks before treatment application

5. Subject with renal failure (Cr > 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).

6. Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease

7. Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)

8. History of malignancy

9. Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)

10. Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.

11. Female subject who is pregnant , lactating, or with a positive pregnancy test

12. History of drug or alcohol abuse (as defined by the Investigator)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Shulov Innovate for Science Ltd. 2012

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Topical skin safety evaluation	Skin irritation	Change in skin clinical presentation up to 5 consecutive treatment days	Yes
Secondary	Systemic absorption	PK profile	During 24 hours following initial application	Yes