Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): 0.1% ZEP-3 cream; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): novel synthetic peptide; novel synthetic peptide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Safety; Tolerability; Pharmacokinetic profile; ZEP-3 Cream (0.1% and 1.0%); administered topically