A Randomized, Evaluator-blinded, Vehicle-controlled Study to Explore the Pharmacodynamic Effects of Omiganan and Omiganan in Combination With Imiquimod in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacodynamic (Biomarkers)
研究概览
简要总结
This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Omiganan
干预措施: Omiganan (Drug)
Imiquimod
干预措施: Imiquimod (Drug)
Omiganan 1% and Imiquimod
干预措施: Omiganan 1% and Imiquimod (Drug)
Omiganan 2.5% and Imiquimod
干预措施: Omiganan 2.5% and Imiquimod (Drug)
Placebo
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic (Biomarkers)
时间窗: Within 2 Weeks
Local biomarker sequencing
Pharmacodynamic (Histology)
时间窗: Within 2 Weeks
Histological parameters assessment
Clinical Evaluation
时间窗: 6 Days
Erythema grading scale
Pharmacodynamic (Immunohistochemistry)
时间窗: Within 2 Weeks
Identification of lymphocytes and lineage cells
Pharmacodynamic (TAP)
时间窗: Within 6 Days
Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)
pharmacodynamic (LSCI)
时间窗: Within 6 Days
Assess cutaneous microcirculation using laster speckle imager
Pharmacodynamic (Colorimetry)
时间窗: Within 6 Days
Colorimetric assessment by erythema grading scale
Pharmacodynamic (Photography)
时间窗: Within 2 Weeks
Photographs of treatment sites will be taken
Pharmacodynamic (Thermography)
时间窗: Within 2 Weeks
Skin temperature measurements will be taken
次要结局
- Local tolerability(2 Weeks)
- Safety (AE)(2 Weeks)
- Safety (Vital Signs)(2 Weeks)
- Safety (Laboratory Safety Testing)(2 Weeks)
- Safety (ECG)(Within 3 Weeks)