NCT02125435已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of ASP2408:AUClast
研究概览
简要总结
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
详细描述
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- •Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator.
- •Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.
- •Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer.
- •Subject is highly likely to comply with the protocol and complete the study.
排除标准
- •Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer.
- •Subject has a history of severe allergic or anaphylactic reactions.
- •Subject is a female of child-bearing potential.
- •Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- •Subject has a positive test for alcohol or drugs of abuse.
- •Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in.
- •Subject has a past history of opportunistic infection.
- •Subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean pulse rate higher than 100 beats per min (bpm).
- •Subject is known positive for human immunodeficiency virus (HIV) antibody.
- •Subject has a positive TB skin test or Quantiferon Gold test or T-SPOT® test at Screening.
- •Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody.
- •Subject's laboratory test results:
- •alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), are greater than 1.5 times the upper limit of normal
- •are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests.
- •Subject received any vaccine within 60 days prior to study drug administration.
- •Subject received any systemic immunosuppressant agent within 2 months prior to study drug administration.
- •Subject has previously received any antibody or therapeutic biologic product prior to study drug administration.
- •Subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration.
- •Subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration.
- •Subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration.
- •Subject is participating in another clinical trial or has participated in another dose group of the current trial.
- •Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -
- •Subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months.
研究组 & 干预措施
ASP2408 dose escalation cohort
Experimental
干预措施: ASP2408 (Drug)
Placebo dose escalation cohort
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic parameter of ASP2408:AUClast
时间窗: Days 1-8, 15, 22, 29, 43, 60, 90
Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
Pharmacokinetic parameter of ASP2408: AUCinf
时间窗: Days 1 -8, 15, 22, 29, 43, 60, 90
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Pharmacokinetic parameter of ASP2408:Cmax
时间窗: Days 1-8, 15, 22, 29, 43, 60, 90
Maximum concentration (Cmax)
Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation
时间窗: up to 90 days
次要结局
- Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot(Days 1-8, 15, 22, 29, 43, 60, 90)
- Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy(Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90)
- Total lymphocyte count(Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90)
- Peripheral lymphocyte subset quantification(Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90)
研究者
研究点 (1)
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