A randomized, evaluator-blinded, vehicle-controlled study to explore the pharmacodynamic effects of omiganan and omiganan in combination with imiquimod in healthy volunteers.

Cutanea Life Sciences0 个研究点开始时间: 2017年1月26日最近更新: 2017年5月22日

适应症

试验速览

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•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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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