EUCTR2021-005429-26-NL进行中（未招募）1 期
Immunological characterization of TLR-7 mediated inflammation and complement activation after prolonged Imiquimod exposure 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
- 10
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 and 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 minimum weight of 50 kg, inclusive;
- •3.Fitzpatrick skin type I-III (Caucasian);
- •4.Female subjects 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 10
- •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.History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial;
- •2.Diagnosed with psoriasis or family history of psoriasis
- •3.History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma);
- •4.Have any current and / or recurrent clinically significant skin condition at the treatment area (e.g. atopic dermatitis); including tattoos;
- •5.Using immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study;
- •6.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;
- •7.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
- •8.Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening;
- •9.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;
- •10.Any vaccination within 30 days prior to initial IMQ dosing or planned during the course of the study with exception of vaccination for SARS-CoV-2;
- •11.Vaccination for SARS-CoV-2 within 14 days prior to initial IMQ dosing, or planned during the course of the study;
- •12.Chronic infection with HIV, hepatitis B (HBV) or hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test at screening excludes a subject;
- •13.A history of ongoing, chronic or recurrent infectious disease;
- •14.Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
- •15.History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
- •16.Previous use of Aldara (imiquimod cream) 3 months prior to the baseline visit;
- •17.Volunteers with clinically relevant infections
- •18.Hypersensitivity for dermatological marker at screening
- •19.Tanning due to sunbathing, excessive sun exposure or a tanning both within 3 weeks of enrollment.
- •20.Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
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