EUCTR2019-003567-21-NL进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at screening:
- •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); inlcuding tattoos
- •5. Previous use of Aldara (IMQ cream) 3 weeks prior to the baseline visit (part A only)
- •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 withing 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 screen.
- •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
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