NL-OMON50971
招募中
不适用
A dermal inflammatory challenge study to evaluate complement activation in healthy volunteers - Local complement activation after dermal inflammatory challenge
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- complement activation
- 发起方
- Centre for Human Drug Research
- 入组人数
- 15
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Healthy male subjects, 18 to 65 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, coagulation, 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
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at
- •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
- •2\. History of skin cancer (basal cell carcinoma, squamous cell carcinoma,
- •3\. Have any current and / or recurrent clinically significant skin condition at
- •the treatment area (i.e. atopic dermatitis); including tattoos;
- •4\. History or presence of post\-inflammatory hyperpigmentation.
- •5\. Using immunosuppressive or immunomodulatory medication within 30 days prior
- •to enrolment or planned to use during the course of the study;
结局指标
主要结局
未指定
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ocal complement activation after dermal inflammatory challengeInflammation / Complement activationMedDRA version: 20.0Level: PTClassification code 10061218Term: InflammationSystem Organ Class: 10018065 - General disorders and administration site conditionsTherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2020-005595-35-NLCentre for Human Drug Research15
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