NL-OMON45716已完成不适用
A randomized, evaluator-blinded, vehicle-controlled study to explore the pharmacodynamic effects of omiganan and omiganan in combination with imiquimod in healthy volunteers. - Topical challenge with omiganan and imiquimod in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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, 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 to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •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 relevant skin condition.
- •5. Previous use of imiquimod/ resiquimod/ gardiquimod
- •6. Known hypersensitivity to the (non)investigational drug, comparative 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 prior to screening
- •13. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
研究者
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