NL-OMON51862已完成不适用
Comparison of skin suction blister method with or without heat plate in a LPS challenge model in healthy volunteers - Influence of heat on skin suction blisters in a LPS challenge model
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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, hematology, blood chemistry,
- •coagulation, blood serology and urinalysis;
- •2. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum
- •weight of 50 kg;
- •3. Fitzpatrick skin type I-III (Caucasian);
- •4. Subjects of childbearing potential must use effective contraception for the
- •duration of the study;
- •5. Able and willing to give written informed consent and to comply with the
- •study restrictions.
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at
- •1. Any disease associated with immune system impairment, including auto-immune
- •diseases, HIV and transplantation patients;
- •2. Any (medical) condition that would, in the opinion of the investigator,
- •potentially compromise the safety or compliance of the patient or may preclude
- •the patient*s successful completion of the clinical trial;
- •3. Any vaccination within the last month; COVID-19 vaccination is allowed up
- •until 2 weeks before study day 1;
- •4. Have any current and / or recurrent pathologically, clinical significant
- •skin condition at the treatment area (i.e. atopic dermatitis); including
- •5. Hypersensitivity for dermatological marker at screening;
- •6. Requirement of immunosuppressive or immunomodulatory medication within 30
- •days prior to enrolment or planned to use during the course of the study;
- •7. Use of topical medication (prescription or over-the-counter [OTC]) within 30
- •days prior to day 1, or less than 5 half-lives (whichever is longer) on lower
- •8. Excessive sun exposure or a tanning booth within 3 weeks of enrolment;
- •9. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times a year;
- •10. Loss or donation of blood over 500 mL within three months prior to
- •11. Volunteers with clinically relevant infections;
- •12. Current nicotine use in excess of 5 cigarettes per day or unable to abstain
- •from smoking during the course of the study (from screening till end of study);
- •13. History of or current drug or substance abuse considered significant by PI
- •(or medically qualified designee), including a positive urine drug screen;
- •14. Covid-19 infection (with positive test result) within the last 4 weeks.
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