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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Centre for Human Drug Research
- 入组人数
- 12
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
相似试验
进行中（未招募）
不适用
A study to evaluate the immune response after administration of lipopolysaccharide (LPS) in the skin of healthy volunteersRegulation of the complement systemNot ApplicableISRCTN15020397Centre for Human Drug Research12
招募中
1 期
Intradermal LPS to study vascular responsesImmunological/cardiovascular conditionsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]CTIS2024-512377-27-00Centre for Human Drug Research32
进行中（未招募）
1 期
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
招募中
不适用
A dermal inflammatory challenge study to evaluate complement activation in healthy volunteerscomplement activationInflammation1002766510014982NL-OMON50971Centre for Human Drug Research15
进行中（未招募）
不适用
Ensayo Clinico para la evaluación no invasiva de la actividad lactasa intesttinal in vivo, mediante la administracción oral de 4-Galactosil-xilosa en sujetos con clinica sugerente de intolerancia a la lactosa”Diagnostico no invasivo de la deficiencia de lactasa intestinalEUCTR2006-002793-21-ESactest S.L.