A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers - Topical challenge with imiquimod in healthy volunteers

Centre for Human Drug Research0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•* Healthy male subjects, 18 to 45 years of age, inclusive
•* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg
•* Fitzpatrick Skin type I-II (Caucasian type)
•* Able to participate 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. Family history of psoriasis
•3. History of pathological scar formation (keloid, hypertrophic scar)
•4. Have any current and / or recurrent pathologically, clinical significant relevant skin condition.
•5. Previous use of imiquimod / resiquimod / gardiquimod
•6. Known hypersensitivity to the investigational drug, comparative drug, drugs of the same class, or any of their excipients.
•7. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
•8. 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
•9. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
•10. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
•11. Loss or donation of blood over 500 mL within three months prior to screening.
•12. 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.

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