A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of the Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.
详细描述
This is a study that will be conducted at a single site in Argentina to characterize the Pharmacokinetics (PK) profile, safety and tolerability of anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in 14 healthy subjects. This is a dose escalation study. Subjects will receive a single dose of an infusion of the biological product or placebo in Stage I where 2 cohorts will be assessed with 2 different doses of INM004. Subjects will receive a repeated dose (3 doses total, every 24 hs) of an infusion of the biological product or placebo in Stage II. The total duration of study participation is 4 weeks for each subject. Subjects will complete a follow-up visit at Day 30 after the dosing. Study duration is expected to last 6 months. The investigational product intent to use is for the prevention of the development of Hemolytic Uremic Syndrome (HUS) associated to Shigatoxin producing Escherichia coli (STEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index: between 19 and
- •Healthy subject, as determined by clinical exam, medical history and laboratory tests (chemistry, hematology and urine, pregnancy test if applicable) performed during the screening visit.
- •Chest x-ray and electrocardiogram within normal ranges.
- •.Willing to participate and sign the informed consent.
- •Women of child-bearing potential using at least two barrier birth control methods.
- •Sexually active men using medically accepted birth control methods, such as condom with spermicide.
排除标准
- •Known hypersensitivity to equine serum.
- •Hypersensitivity to any of the components of the pharmaceutical preparation.
- •History of severe allergic reactions to any type of antigen.
- •History of mental illness.
- •Participation in another clinical research study within 90 days6 months prior to the start of this study
- •History of alcohol or drug abuse.
- •History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, hematological, neurological disease.
- •Having received contrast substances for radiological studies of any kind in the two weeks prior to the start of the study.
- •Receiving or having received any prescription drug within the two weeks prior to the start of the study, including oral contraceptives in women of child-bearing potential.
- •Having received more than three doses of any over-the-counter medication during the week prior to the start of the study or any medication within two days prior to the hospitalization
- •Having given blood within a period of under 2 months prior to the start of the study
- •Documented infection with HIV, hepatitis B and/or hepatitis C.
- •Pregnancy
- •History of asthma, allergy, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
- •History of vaccination within the month prior to the start of the study.
- •Infectious disease requiring hospitalization within the month prior to the inclusion in the study.
- •Having received a transfusion of blood products within three months prior to the inclusion in the study
- •Having received any medication within 14 days prior to the inclusion in the study.
- •Family relation or work relation to the personnel of the research group.
研究组 & 干预措施
Stage II- Placebo Repeated Dose
干预措施: Placebo (Other)
Stage I - Drug: INM004 Dose 1
干预措施: Drug: INM004 Dose 1 (Biological)
Stage I - Placebo Dose 1
干预措施: Placebo (Other)
Stage I- Drug: INM004 Dose 2
干预措施: Drug: INM004 Dose 2 (Biological)
Stage I- Placebo Dose 2
干预措施: Placebo (Other)
Stage II- Drug: INM004 Repeated Dose
干预措施: Drug: INM004- Repeated dose (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 4 weeks
Time of Maximum concentration observed (Tmax)
时间窗: 4 weeks
Area Under the Curve [AUC]
时间窗: 4 weeks
Maximum Plasma Concentration [Cmax]
时间窗: 4 weeks
Elimination half-life (t½)
时间窗: 4 weeks
次要结局
- Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0(4 weeks)