NCT02139657已完成1 期
An Open-label, Single-arm Study to Evaluate the Safety and Antibody Titers Specific to the Rabies Virus in Healthy Subjects After Receiving a Single Dose of Intramuscularly Administered Rabies Immune Globulin (Human)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rabies Virus Antibody Titer
研究概览
简要总结
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of RIG-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.
- •Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice contraception by a method of proven reliability (includes abstinence) for the duration of the study.
排除标准
- •Pregnant or lactating females.
- •Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
- •Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
- •History of angioedema or nephrotic syndrome.
- •Non-controlled arterial hypertension.
- •Anemia at screening.
- •Significant proteinuria (> 1 + on urine dipstick) and/or has a history of acute renal failure and/or severe renal impairment or a blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal at screening and/or currently receiving dialysis.
- •Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.
- •Previously received the rabies vaccine and/or rabies immune globulin.
- •Received infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin.
- •Known adverse reaction to administration of any immune globulin or other blood/plasma products.
- •Experienced anaphylactic shock with the administration of blood/plasma products.
- •Known medical history of selective immunoglobulin A (IgA) deficiency.
- •Received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening.
- •Expects to receive oral or topical non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antihypertensives, and/or antihistamines 24 hours before or after investigational product administration during the Baseline/Treatment, Study Day 0 visit.
- •Currently receiving any anti-viral treatment.
- •Screening laboratory results indicative of an acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V).
- •Participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational products within the previous 3 months.
- •Not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product.
- •History of a psychiatric illness requiring hospitalization.
- •Known substance or prescription drug abuse in the past 12 months.
- •Any active medical illness that the Investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.
结局指标
主要结局
Rabies Virus Antibody Titer
时间窗: 10 days post-RIG-C dosing
次要结局
- Number of subjects who discontinue due to adverse events(21 days)
研究者
研究点 (1)
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