NCT03047317已完成1 期
A Phase I Pharmacokinetic Study of MABp1 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Time to Peak Plasma Concentration
研究概览
简要总结
This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate bone marrow function as defined as:
- •absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
- •platelet count > 150,000/mm3
- •hemoglobin of ≥ 10 g/dL
- •Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
- •Adequate hepatic function defined as:
- •total bilirubin ≤ 1.5 times lab ULN.
- •alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
- •For WOCBP, a negative pregnancy test at screening. For subjects with reproductive potential, a willingness to utilize contraception during the study and for at least 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and for at least 3 months after study completion.
- •Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.
排除标准
- •Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- •Uncontrolled or significant cardiovascular disease, including:
- •A myocardial infarction within the past 6 months.
- •Uncontrolled angina within the past 3 months.
- •Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Classes II or higher.
- •Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic).
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- •Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- •Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •Infectious disease:
- •CRP >30 mg/L, or infection requiring treatment with antibiotics within 3 weeks prior to Screening,
- •Positive HIV, RPR, Hepatitis C antibody, or IGRA
- •Immunodeficiency by history.
- •Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
- •Major surgery within 28 days prior to Day
- •WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to randomization, for the duration of the study, and for at least 3 months after the last dose of study medication.
- •History of progressive multifocal leukoencephalopathy or other demyelinating disease.
结局指标
主要结局
Time to Peak Plasma Concentration
时间窗: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Half Life
时间窗: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Area under the plasma concentration versus time curve
时间窗: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Peak Plasma Concentration
时间窗: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
次要结局
- Incidence of treatment emergent adverse events(2 weeks)
研究者
研究点 (2)
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