Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

Study Overview
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Brief Summary
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This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.

Official Title
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A Randomized, Evaluator-blinded, Vehicle-controlled Study to Explore the Pharmacodynamic Effects of Omiganan and Omiganan in Combination With Imiquimod in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Omiganan
* Drug: Imiquimod
* Drug: Omiganan 1% and Imiquimod
* Drug: Omiganan 2.5% and Imiquimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg. Fitzpatrick skin type I-III (Caucasian) Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose. Able and willing to give written informed consent and to comply with the study restrictions. Exclusion Criteria: Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients Family history of psoriasis History of pathological scar formation (keloid, hypertrophic scar) Have any current and / or recurrent pathologically, clinical significant skin condition. Previous use of imiquimod/ resiquimod/ gardiquimod Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients. Hypersensitivity for dermatological marker at screening Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study. Use of topical medication (prescription or over-the-counter [OTC]) within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omiganan<br> | Drug: Omiganan<br>* Omignan 1%, 2.5%<br>|
| Experimental: Imiquimod<br> | Drug: Imiquimod<br>* Imiquimod 15mg<br>|
| Experimental: Omiganan 1% and Imiquimod<br> | Drug: Omiganan 1% and Imiquimod<br>* Omiganan 1% and Imiquimod<br>|
| Experimental: Omiganan 2.5% and Imiquimod<br> | Drug: Omiganan 2.5% and Imiquimod<br>* Omiganan 2.5% and Imiquimod<br>|
| Placebo Comparator: Placebo<br>Vehicle | Drug: Placebo<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation | Erythema grading scale | 6 Days | 
| Pharmacodynamic (Biomarkers) | Local biomarker sequencing | Within 2 Weeks | 
| Pharmacodynamic (Histology) | Histological parameters assessment | Within 2 Weeks | 
| Pharmacodynamic (Immunohistochemistry) | Identification of lymphocytes and lineage cells | Within 2 Weeks | 
| Pharmacodynamic (TAP) | Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP) | Within 6 Days | 
| pharmacodynamic (LSCI) | Assess cutaneous microcirculation using laster speckle imager | Within 6 Days | 
| Pharmacodynamic (Colorimetry) | Colorimetric assessment by erythema grading scale | Within 6 Days | 
| Pharmacodynamic (Photography) | Photographs of treatment sites will be taken | Within 2 Weeks | 
| Pharmacodynamic (Thermography) | Skin temperature measurements will be taken | Within 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerability | Visual Analogue Scale (NRS) pruritus and pain | 2 Weeks | 
| Safety (AE) | Adverse Events will be collected throughout the study | 2 Weeks | 
| Safety (Vital Signs) | Vital Signs will be collected throughout the study | 2 Weeks | 
| Safety (Laboratory Safety Testing) | Lab samples collected in various timepoints within the study | 2 Weeks | 
| Safety (ECG) | ECGs will be collected before beginning and end of study | Within 3 Weeks |