NCT00354263已完成1 期
IMP321 Phase I Study of Four Increasing Doses (3, 10, 30 and 100 µg) of a New Immunostimulatory Factor (IMP321) Given Alone or as an Adjuvant to a Reference Flu Antigen in Healthy Young Male Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate clinical and laboratory safety and tolerability profiles
研究概览
简要总结
This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.
详细描述
This study is divided in two steps:
Step 1 (20 volunteers): IMP321 will be given alone and tested versus placebo (physiological saline)
In this first step, 4 group doses (of four subjects each) will be evaluated versus a placebo group of 4 subjects:
- Group IMP321 alone at 3 µg,
- Group IMP321 alone at 10 µg,
- Group IMP321 alone at 30 µg,
- Group IMP321 alone at 100 µg.
In order to complete these groups, four successive cohorts of volunteers will be studied:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •able to give a written informed consent ;
- •healthy male volunteers aged between 18 and 40 years;
- •with body mass index (weight/height²) in the range 18 to 30 kg/m²;
- •registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
- •able to comply with protocol requirements, including blood and urine sample collections as defined in the protocol;
- •not flu vaccination in the last two years.
排除标准
- •who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
- •with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
- •who have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
- •who forfeit their freedom by administrative or legal award or who were under guardianship ;
- •unwilling to give their informed consent ;
- •who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
- •who have a history of allergy or intolerance to the study drug ;
- •who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
- •who are known or suspected alcohol or drug abusers ;
- •who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
- •who undergo surgery or have donated blood within 1 month prior to the start of the study ;
- •who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
- •who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
- •who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
- •who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.
研究组 & 干预措施
A
Placebo Comparator
PBS injected alone in step 1 or mixed with Aggripal in step 2
干预措施: saline (Biological)
B
Experimental
干预措施: IMP321 (Biological)
结局指标
主要结局
To evaluate clinical and laboratory safety and tolerability profiles
时间窗: 6 weeks
次要结局
- To determine T cell response induction efficacy(6 weeks)
研究者
研究点 (1)
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