NL-OMON55304已完成不适用
A randomized, evaluator-blind, vehicle controlled, parallel group study to explore the effects of the anti-inflammatory drug prednisolone in a TLR4 and TLR7 challenge model in healthy volunteers - Anti-inflammatory drugs in TLR4 and TLR7 topical challenge model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
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 99（—）
入选标准
- •1. Healthy male or female subjects (part B males only), 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-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. Any vaccination within the last 3 months; COVID19 vaccination is allowed up
- •until 4 weeks prior to the first prednisolone/placebo dosing, and from 2 weeks
- •after the last prednisolone/placebo dosing.
- •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); including tattoos
- •5. Previous use of Aldara (IMQ cream) 3 weeks prior to the baseline visit (part
- •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 (part A and B), or donation of plasma within 14 days of screening
- •(part B only)
- •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
- •16. Current smoker and/or regular user of other nicotine-containing products
- •(e.g., patches); or positive urine cotinine test at screening (part B only)
- •17. History of or current drug or substance abuse considered significant by
- •the PI (or medically qualified designee), including a positive urine drug
- •18. Subjects that test positive for a SARS-CoV-2 infection
- •19. Subjects with a BMI > 30 and/or cardiovascular, respiratory or immune
- •system disorders
研究者
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