Development of a dermal TLR4 challenge in healthy volunteers. - Skin inflammation challenge with TLR4 agonist

Centre for Human Drug Research0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•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.

•Eligible subjects must meet none of the following exclusion criteria at screening:
•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. 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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