Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

Maruho

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omiganan 2.5% and Imiquimod; Drug: Placebo; Drug: Omiganan; Drug: Imiquimod; Drug: Omiganan 1% and Imiquimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT03071679

CLS001-CO-PR-015

2016-004702-34 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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16 participants in 5 patient groups, including a placebo group

Omiganan

Experimental group

Treatment:

Drug: Omiganan

Imiquimod

Experimental group

Treatment:

Drug: Imiquimod

Omiganan 1% and Imiquimod

Experimental group

Treatment:

Drug: Omiganan 1% and Imiquimod

Omiganan 2.5% and Imiquimod

Experimental group

Treatment:

Drug: Omiganan 2.5% and Imiquimod

Placebo

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Placebo