NL-OMON55995已完成不适用
A study in healthy volunteers to evaluate the effect of repeated LPS skin challenges in a single individual - Effect of repeated local LPS challenges in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
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, haematology, blood chemistry,
- •blood serology and urinalysis. In the case of uncertain or questionable
- •results, tests performed during screening may be repeated before enrollment to
- •confirm eligibility or judged to be clinically irrelevant for healthy subjects;
- •2. Body mass index (BMI) between 18 and 30 kg/m2 and 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
- •1. History of pathological scar formation (keloid, hypertrophic scar) or
- •keloids or surgical scars in the target treatment area (lower arm and upper
- •back) that in the opinion of the investigator, would limit or interfere with
- •dosing and/or measurement in the trial;
- •2. Have any current and / or recurrent pathologically, clinical significant
- •skin condition at the treatment area (lower arm and upper back, i.e. atopic
- •dermatitis); including tattoos;
- •3. Requirement of immunosuppressive or immunomodulatory medication within 30
- •days prior to enrolment or planned to use during the course of the study;
- •4. Known immunodeficiency
- •5. Use of topical medication (prescription or over-the-counter [OTC]) in local
- •treatment area or any medication that may interfere with the study objectives
- •as judged by the investigator within 30 days of study drug administration, or
- •less than 5 half-lives (whichever is longer)
- •6. Participation in an investigational drug or device study within 3 months, or
- •5 half-lives whichever is longer, prior to screening or more than 4 times in
- •the past year.
- •7. Loss or donation of blood over 500 mL within three months prior to screening
- •or donation of plasma within 14 days of screening
- •8. 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.
- •9. Pregnant, a positive pregnancy test, intending to become pregnant during the
- •study conduct, or breastfeeding.
- •10. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV
- •ab), or human immunodeficiency virus antibody (HIV ab) at screening.
- •11. A history of ongoing, chronic or recurrent infectious disease
- •12. Hypersensitivity for dermatological marker at screening
- •13. Current smoker and/or regular user of other nicotine-containing products
- •(e.g., patches)
- •14. History of or current drug or substance abuse considered significant by the
- •PI (or medically qualified designee), including a positive urine drug screen.
- •15. Presence of current, clinically relevant infections
- •16. Any vaccination within the last 4 weeks before day 1. Intention to receive
- •any vaccination(s) before the last day of follow-up.
- •17.Prolonged exposure of the investigational skin (lower arm, back) to sunlight
- •(including artificial tanning)
研究者
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