ISRCTN15020397进行中（未招募）Unknown
An intradermal LPS challenge study to evaluate local complement activation in healthy volunteers
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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, haematology, blood chemistry, blood serology, coagulation 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. Subjects and their partners of childbearing potential must use effective contraception for the duration of the study. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, unless they meet one of the following conditions:
- •4.1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks after surgical bilateral oophorectomy with or without hysterectomy;
- •4.2. Post-hysterectomy.
- •5. Able and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area of the upper back that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial;
- •2. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis); including tattoos;
- •3. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel 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.
- •4. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study;
- •5. 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
- •6. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- •7. Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening
- •8. Any history or current presence of a (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.
- •9. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening.
- •10. Abnormal findings in the resting ECG at screening defined as:
- •10.1 QTcF> 450 or < 300 ms for men and QTcF> 470 or < 300 ms for women;
- •10.2 Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm);
- •10.3 Personal or family history of congenital long QT syndrome or sudden death;
- •10.4 ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate
- •10.5 QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
- •10.6 Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker.
- •11. Chronic infection with HIV, hepatitis B (HBV) or hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test at screening excludes a subject.
- •12. Presence of current or a history of ongoing, chronic or recurrent infections or infectiousdisease. Exception for plantar warts and onychomycosis.
- •13. (History of) autoimmune disease, such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune-inflammatory diseases.
- •14. Hypersensitivity for dermatological marker at screening.
- •15. Current smoker and/or regular user of other nicotine-containing products (e.g., patches).
- •16. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
- •17. Use of any prescription or OTC medications within 7 days or 5 half-lives (whichever is longer) prior to LPS administration, unless, in the opinion of the Investigator, the medication will not interfere with the study proced
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