E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062249 |
E.1.2 | Term | Skin inflammation |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Objective - To explore the pharmacodynamics effects of topically applied OMN on o Tape-stripped skin of healthy volunteers o Tape-stripped and IMQ-primed skin of healthy volunteers o Tape-stripped skin prior to IMQ application
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives • To assess safety and tolerability of topically applied OMN in combination with IMQ
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 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. 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg. 3. Fitzpatrick skin type I-III (Caucasian). 4. 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. 5. Able and willing to give written informed consent and to comply with the study restrictions.
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E.4 | Principal exclusion criteria |
1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients 2. Family history of psoriasis 3. History of pathological scar formation (keloid, hypertrophic scar) 4. Have any current and / or recurrent pathologically, clinical significant skin condition. 5. Previous use of imiquimod/ resiquimod/ gardiquimod 6. Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients. 7. Hypersensitivity for dermatological marker at screening 8. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study. 9. 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 10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. 11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. 12. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening 13. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacodynamic endpoints - Local (biopsy) biomarkers (including but not limited to IL-8, IFN-α, IFN-β, IFN-ɣ, MXA, MX1, IL-6, IL-10, CCL20 and HBD-2) - Histology (HE) - Immunohistochemistry (CD1a, HLADR, CD8+, CD4+, CD14+, CD11c) - Transdermal Analysis Patch (IL-8, IFN-α, IL-6, IL-10, CCL20 and HBD-2) - Perfusion by Laser speckle contrast imaging (LSCI) - Colorimetry - Clinical evaluation (erythema grading scale) - Photography (total body imaging); erythema index - Thermography - Skin microbiome (healthy and treated skin)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Tolerability / safety endpoints Adverse events (AEs) - Vital signs - 12-leads ECGs - Local tolerance (Visual Analogue Scale (NRS) pruritus and pain) - Circulating cytokines (IFN-α, IFN-ɣ)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 11 |
E.8.3 |
The trial involves single site in the Member State concerned
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E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |