Development of a dermal TLR4 challenge in healthy volunteers

Centre for Human Drug Research0 个研究点目标入组 18 人开始时间: 2020年11月16日最近更新: 2021年8月30日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34293819/ (added 18/08/2021)

•1. Healthy male 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
•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. Able and willing to give written informed consent and to comply with the study restrictions

•1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
•2. Any vaccination within the last 3 months
•3. Family history of psoriasis
•4. History of pathological scar formation (keloid, hypertrophic scar)
•5. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis)
•6. Hypersensitivity for dermatological marker at screening
•7. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study
•8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment
•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 screening. Or the donation of plasma within 14 days prior to screening
•11. Current smoker and/or regular user of other nicotine-containing products (e.g., patches)
•12. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen

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