NL-OMON53274已完成不适用
An intradermal LPS challenge study to evaluate complement activation in healthy volunteers - In vivo complement activation after LPS challenge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 64（—）
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 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
- •2. Body mass index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50 kg,
- •3. Fitzpatrick skin type I-III (Caucasian);
- •4. Subjects and their partners of childbearing potential must use effective
- •contraception (see paragraph 4.4.2) 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:
- •-Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks
- •after surgical bilateral oophorectomy with or without hysterectomy;
- •-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
- •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
- •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:*
- •-QTcF> 450 or < 300 ms for men and QTcF> 470 or < 300 ms for women;*
- •-Notable resting bradycardia (HR*<*45 bpm) or tachycardia (HR*>*100 bpm);*
- •-Personal or family history of congenital long QT syndrome or sudden death;*
- •-ECG with QRS and/or T wave judged to be unfavorable for a consistently
- •accurate 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);*
- •-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 infectious disease. Exception for plantar warts and
- •onychomycosis.
- •13. 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 s
研究者
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