NCT00333528已完成1 期
A Phase 1, Randomized, Observer-Blinded, Single Dose, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Plasma-Derived Human Butyrylcholinesterase (HuBChE) Administered Intramuscularly (IM)
Baxalta now part of Shire1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2007年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Frequency and severity of local and systemic adverse events (AEs)
研究概览
简要总结
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults. HuBChE, which occurs naturally in human plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers will receive a single intramuscular infusion of either HuBChE or normal saline placebo. The volunteers will remain in the study for 90 (+/- 7) days. For the first 3 days following dose administration, they will remain at the clinical trial site as an inpatient and will be closely monitored for patient safety. Afterwards, they will return to the trial site (at pre-determined intervals) as an outpatient for a further 8 visits, where patient safety will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •The volunteer is between 18 and 55 years of age (inclusive) at the time of administration of HuBChE.
- •The volunteer is in good health as determined by the Investigator (Study Doctor) from a medical history and physical examination.
- •The volunteer has clinical chemistry, hematology, coagulation, and urinalysis laboratory values within acceptable ranges or deemed clinically insignificant by the Principal Investigator (PI) and Project Medical Monitor.
- •The volunteer has a normal electrocardiogram (ECG) or one with clinically insignificant findings as deemed by the PI.
- •The volunteer is willing to have his or her blood samples stored for future HuBChE research studies.
- •The volunteer has signed the Informed Consent Form (ICF) and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
- •The volunteer agrees not to donate blood during the trial or for at least 2 months following the 90 day study visit.
- •The volunteer is willing to comply with the requirements of the protocol through the Post-Infusion Day 90 (± 7 days) visit.
- •Female volunteers must be of non-childbearing potential (i.e., surgically sterilized or postmenopausal), or must not be pregnant (as indicated by a negative urine pregnancy test within 1 day prior to HuBChE administration) or nursing, and must use two types of acceptable forms of Food and Drug Administration (FDA) approved birth control methods, including:
- •Progesterone only hormonal types of birth control (such as implants or birth control pills) or an intrauterine device (IUD) and
- •an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.) during the period beginning from 30 days before HuBChE administration through completion of the study. Completion of the study is defined as completing the acute phase of the study (Day 45 [± 3 days] visit).
排除标准
- •The volunteer demonstrates predisposition to thrombus formation as determined by past medial history, and family history.
- •The volunteer has a history of anaphylactoid reaction or other serious adverse reactions to blood products.
- •The volunteer has a history of allergic reaction to procainamide or to its metabolite, p-aminobenzoic acid.
- •The volunteer has been diagnosed with alcohol or drug abuse within the 12 months prior to study screening or offers a history of alcohol or drug abuse within the 12 months prior to screening.
- •The volunteer has a positive result on a urine drug screen that tests for common substances of abuse, such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable.)
- •The volunteer has a previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within the previous 12 months; routine administration of more than one medication to control anxiety, mood or sleep disorder; or history of suicide attempt.
- •The volunteer has received any blood products or immune globulin in the previous six months.
- •The volunteer has donated blood within 56 days prior to receipt of study product (Day 0).
- •The volunteer has a deficiency of immunoglobulin A (IgA) as determined on screening.
- •The volunteer has a current or past medical history for any condition which, in the opinion of the PI and/or Project Medical Monitor (PMM), might place him or her at risk by participating in the study.
- •Personal or family history (in first degree relatives) of significant neuromuscular disease (as determined by the PI).
- •Female volunteer is pregnant (must have a negative urine pregnancy test within 1 day of receipt of HuBChE), lactating, or unwilling to use 2 types of an acceptable FDA-approved form of contraception from time of screening through completion of the Day 45 (± 1 day) study visit.
- •Current use, receipt within the previous 14 days, or intent to use during the 14 days after receiving drug product of drugs that may be metabolized, inhibited or otherwise affected by BChE.
- •The volunteer has a clinically significant abnormality on the ECG.
- •The volunteer has any laboratory values outside acceptable ranges that are clinically significant as assessed by the Investigator and/or PMM.
- •The volunteer tests positive for HIV, HCV or HBV at screening.
- •The volunteer has an acute illness, evidence of significant active infection, or evidence of systemic disease at time of enrollment that in the opinion of the PI would place the volunteer at an unacceptable risk for injury.
- •The volunteer has a temperature >100.4°F at the time of dose administration.
- •The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
- •The volunteer is currently using tobacco products.
- •Participants in other clinical trials in the past 60 days.
研究组 & 干预措施
1
Experimental
Administration of one dose of the active drug (6 volunteers)
干预措施: Human butyrylcholinesterase (HuBChE) derived from human plasma (Drug)
结局指标
主要结局
Frequency and severity of local and systemic adverse events (AEs)
时间窗: until post-infusion Day 90 (+/- 7 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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