NL-OMON51378已完成不适用
Immunological characterization of TLR-7 mediated inflammation and complement activation after prolonged Imiquimod exposure in healthy volunteers - In vivo immune activation after prolonged TLR-7 inflammatory challenge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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,
- •blood serology and urinalysis. In the case of uncertain or questionable
- •results, tests performed during screening may be repeated before randomization
- •to confirm eligibility or judged to be clinically irrelevant for healthy
- •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 and their partners 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. History of pathological scar formation (keloid, hypertrophic scar) or
- •keloids or surgical scars in the target treatment area that in the opinion of
- •the investigator, would limit or interfere with dosing and/or measurement in
- •2. Diagnosed with psoriasis or family history of psoriasis
- •3. History of skin cancer (basal cell carcinoma, squamous cell carcinoma,
- •4. Have any current and / or recurrent clinically significant skin condition at
- •the treatment area (e.g. atopic dermatitis); including tattoos;
- •5. Using immunosuppressive or immunomodulatory medication within 30 days prior
- •to enrolment or planned to use during the course of the study;
- •6. 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;
- •7. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times a year;
- •8. Loss or donation of blood over 500 mL within three months prior to screening
- •or donation of plasma within 14 days of screening;
- •9. 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;
- •10. Any vaccination within 30 days prior to initial IMQ dosing or planned
- •during the course of the study with exception of vaccination for SARS-CoV-2;
- •11. Vaccination for SARS-CoV-2 within 14 days prior to initial IMQ dosing, or
- •planned during the course of the study;
- •12. Chronic infection with HIV, hepatitis B (HBV) or hepatitis C (HCV). A
- •positive HBV surface antigen (HBsAg) test at screening excludes a subject;
- •13. A history of ongoing, chronic or recurrent infectious disease;
- •14. Current smoker and/or regular user of other nicotine-containing products
- •(e.g., patches);
- •15. History of or current drug or substance abuse considered significant by the
- •PI (or medically qualified designee), including a positive urine drug screen.
- •16. Previous use of Aldara (imiquimod cream) 3 months prior to the baseline
- •17. Volunteers with clinically relevant infections
- •18. Hypersensitivity for dermatological marker at screening
- •19. Tanning due to sunbathing, excessive sun exposure or a tanning both within
- •3 weeks of enrollment.
- •20. Pregnant, a positive pregnancy test, intending to become pregnant, or
- •breastfeeding
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