Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

• Status: Completed
• Trial end date: 2017-03-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.
• Treatments: Antimicrobial Cationic Peptides; Imiquimod

Criteria

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