NL-OMON28349尚未招募不适用
A randomized, evaluator-blind, vehicle controlled, parallel group study to explore the effects of the anti-inflammatory drug prednisolone in a TLR7 challenge model with imiquimod in healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 24
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy male or 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 subjects;
- •2. Body mass index (BMI) between 18 and 30 kg/m2 and a maximum weight of 100 kg, inclusive;
- •3. Fitzpatrick skin type I-II (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
- •1. Any vaccination within the last 3 months;
- •2. Family history of psoriasis;
- •3. History of pathological scar formation (keloid, hypertrophic scar);
- •4. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis);
- •5. Previous use of Aldara (IMQ cream) 3 weeks prior to the baseline visit
- •6. Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients;
- •7. Hypersensitivity for dermatological marker at screening;
- •8. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
- •9. 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
- •10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
- •11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- •12. Loss or donation of blood over 500 mL within three months prior to screening
- •13. 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.
- •14. Latent Diabetes Mellitus
- •15. Volunteers with clinically relevant infections
研究者
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