NCT00448253已完成1 期
Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Anti-PA antibody and TNA for PK analyses.
研究概览
简要总结
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.
详细描述
- The test product is Anthrax Immune Globulin Intravenous (Human), NP-015.
- The product is supplied as a sterile liquid suitable for IV administration.
- Product potency is expressed in units of anthrax toxin neutralization assays(TNA) per vial.
- This study is a phase 1, placebo controlled, dose-ranging study in healthy volunteers. Subjects will receive one of three NP-015 doses (210, 420 or 840 units TNA) or equal volumes of saline placebo.
- Enrolment will be sequential, starting at the lowest NP-015 dose with accrual into the next higher dose after all patients at the lower dose have been treated.
- The first 3 Cohorts: The Subjects will be recruited in cohorts of 24, with placebo controls included in each dosing group. In each cohort, subjects will be randomized to receive either NP-015 (N = 18/dosing group) or placebo (N = 6/dosing group). For Cohort 4: 20 Subjects will be recruited and dosed at the highest dose with 2 additional product lots (10 subjects per lot).
Plasma samples will be drawn over 84 days. Plasma will be tested for anti-anthrax antibodies by a protective antigen (anti-PA) ELISA and toxin neutralization assay (TNA).
- Serological testing for HIV, HBV and HCV will be conducted at screening to determine eligibility. Nucleic acid amplification testing (NAT) and serological testing for HIV, HBV and HCV will be conducted at baseline (day -1) and at the final visit (day 84 or early withdrawal). NAT for parvovirus B19 will be conducted at baseline (day -1), day 14, and the final visit (day 84 or early withdrawal).
- Safety data will be collected throughout the 84-day study.
Screening (within 28 days prior to Baseline):
- Informed consent
- Review of admission criteria
- Medical history, general physical examination, vital signs, electrocardiogram and concomitant medications will be recorded
- Hematology, blood chemistry, urinalysis, viral serology (anti-HIV-1/2, Anti-HCV, HBsAg, anti-HBc)
- Serum pregnancy test for all female subjects
- Drug screen (urine)
- Blood collection for anti-PA antibody and toxin neutralization assay (TNA) assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female
- •Age 18/19 (dependent on local age of majority) - 55 years
- •Body mass index of 19 - 29
- •For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
- •Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
- •IUD inserted at least 3 months prior to dosing.
- •For female subjects who are postmenopausal < 2 years an FSH ≥ 40 mIU/mL must be obtained. If the FSH is < 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above).
- •For males that have not had a vasectomy, willingness to use a condom with spermicide for the duration of the study. Also, male subjects must not donate sperm for the duration of the study.
- •Normal and healthy as determined by medical history, physical exam, ECG, vital signs and laboratory tests of liver, kidney and hematological functions
- •Written informed consent
排除标准
- •Heavy smokers (>10 cigarettes/day) or individuals using smokeless tobacco or nicotine containing products
- •Use of any investigational product within the past 30 days
- •Recipient of any blood product within the past 12 months
- •Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline
- •Females with a hemoglobin level < 12 g/dL
- •Males with a hemoglobin level < 13 g/dL
- •History of hypersensitivity to blood products
- •History of allergy to latex or rubber
- •History of IgA deficiency
- •Pregnancy or lactation
- •Positive serology test for HIV or HCV, positive test for HBV as determined by HBsAg.
- •History of, or suspected substance abuse problem (including alcohol)
- •Failure of drug test at screening or baseline
- •Failure of alcohol test at baseline or consumption of alcoholic beverages within 48 hours of baseline
- •History of anthrax vaccination with AVA or any other anthrax vaccine
- •Individuals with planned medical procedures that will occur during the study
- •Use of prescription medications within 7 days prior to baseline, or anticipated use during the study (with the exception of hormonal contraceptives for females)
- •Use of over-the-counter, herbal medications or vitamins within 7 days of study admission
- •An opinion of the investigator that it would be unwise to allow participation of the subject in the study
结局指标
主要结局
Anti-PA antibody and TNA for PK analyses.
时间窗: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84
次要结局
- Viral Markers for safety.(screen, baseline, and Day(s)14 and 84)
- Dose proportionality analyses.(screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84)
- Blood Chemistry(screen, baseline, and D0 hours 0,1,2 and day(s) 1,3,7,14,28, and 84)
- Urinalysis(screen, baseline, and D0 hours 0 and day(s) 1,3,7,14,28, and 84)
- Hematology (haptoglobin and free hemoglobin at baseline and day 1)(screen, baseline, Day(s) 1,3,7,14,28, and 84)
研究者
研究点 (2)
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