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

NCT01863160 | Completed Phase 1 DMC

• 1 other identifier: ZEP - 001 - IL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetic profile; ZEP-3 Cream (0.1% and 1.0%); administered topically

Outcome Measures

Primary Outcomes (1)

• Topical skin safety evaluation

  Skin irritation

  Change in skin clinical presentation up to 5 consecutive treatment days

Secondary Outcomes (1)

• Systemic absorption

  During 24 hours following initial application

Study Arms (2)

0.1% ZEP-3 cream

OTHER

250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily

Drug: 0.1% ZEP-3 cream

placebo

OTHER

250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily

Drug: placebo

Interventions

0.1% ZEP-3 cream DRUG

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

Also known as: novel synthetic peptide

0.1% ZEP-3 cream

placebo DRUG

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

Also known as: novel synthetic peptide

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
• Subject, either men or women is between 18 and 50 years of age.
• Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
• Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
• Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
• Subject is willing to participate in the study and adhere to the study protocol
• Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.

You may not qualify if:

• Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
• Dark skinned persons whose skin color prevents ready assessment of skin reactions
• 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
• UV therapy or significant UV exposure in the four weeks before treatment application
• Subject with renal failure (Cr \> 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
• Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
• Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
• History of malignancy
• Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
• Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
• Female subject who is pregnant , lactating, or with a positive pregnancy test
• History of drug or alcohol abuse (as defined by the Investigator)

Sponsors & Collaborators

• Shulov Innovate for Science Ltd. 2012: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Study Officials

• Aviv Barzily, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 27, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 20, 2014

Record last verified: 2013-08

Locations

IL (1)