NCT01565681已完成1 期
A Phase 1 Single Ascending Dose Study of ASKP1240 in Healthy Male and Female Volunteers
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
- 109
- 试验地点
- 1
- 主要终点
- Pharmacodynamic variable: Individual subject cell surface antigen (CD40) occupancy levels over time
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
- •The female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L)
- •Male subject agrees to no sperm donation until end of study or 90 days post dose, whichever is longer
- •The subject is highly likely to comply with the protocol and complete the study
- •The subject has a negative urine screen for drugs of abuse, and negative blood or breathalyzer alcohol screen at Screening and clinic admission on Day 1
排除标准
- •The subject has a history of severe allergic or anaphylactic reactions
- •The subject has 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 prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- •The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
- •The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or pulse rate higher than 100 beats per min (bpm), either at screening or clinic check in (blood pressure measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
- •The subject is known positive for human immunodeficiency virus (HIV) antibody
- •The subject has a positive test for hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg)
- •The subject has at screening or clinic check in that:
- •white blood cell count (WBC) is < 3.5 or > upper limit of normal
- •absolute neutrophil count (ANC) is <1.5 or > upper limit of normal
- •platelet count (PLT) is outside the normal limit
- •serum creatinine, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) are > upper limit of normal
- •creatine phosphokinase (CPK) is > two times upper limit of normal
- •international normalized ratio (INR) is > upper limit of normal
- •OR remaining laboratory tests are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per protocol laboratory tests
- •The subject has received a vaccine within 60 days prior to study drug administration
- •The subject has received any systemic immunosuppressant agent within 6 months prior to study drug administration.
- •The subject has received any antibody or biologic product within 6 months prior to study drug administration
- •The subject has received any systemic steroid within 2 months prior to study drug administration
- •The subject has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines (CAM) and excluding over-the-counter (OTC) allergy medications, nasal steroids, nasal inhalers, oral contraceptives, stable hormone replacement therapy (HRT; per Investigator judgment and dose change not expected during study), and intermittent acetaminophen, within 14 days prior to study drug administration
- •The subject has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
- •The subject is participating in another clinical trial or has participated in another dose group of the current trial
- •The subject has donated or has had significant blood loss or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to dosing
- •The subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to Screening
- •The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis, pulmonary embolism and varices
- •The subject has a positive test for tuberculosis
研究组 & 干预措施
Arm A: ASKP1240 lowest dose
Experimental
干预措施: ASP1240 (Drug)
Arm B: ASKP1240 second lowest dose
Experimental
干预措施: ASP1240 (Drug)
Arm C: ASKP1240 third lowest dose
Experimental
干预措施: ASP1240 (Drug)
Arm D: ASKP1240 fourth lowest dose
Experimental
干预措施: ASP1240 (Drug)
Arm E: ASKP1240 fifth lowest dose
Experimental
干预措施: ASP1240 (Drug)
Arm F: ASKP1240 middle dose
Experimental
干预措施: ASP1240 (Drug)
Arm G: ASKP1240 sixth highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm H: ASKP1240 fifth highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm I: ASKP1240 fourth highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm J: ASKP1240 third highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm K: ASKP1240 second highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm L: ASKP1240 highest dose
Experimental
干预措施: ASP1240 (Drug)
Arm M: Placebo
Placebo Comparator
Sodium Chloride solution
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic variable: Individual subject cell surface antigen (CD40) occupancy levels over time
时间窗: Days 1-3, 5, 8,15, 22, 29, 43, 60, 75, and 90
binding of ASKP1240-biotin to B cells
Pharmacokinetics profile: AUCinf and Cmax
时间窗: Days 1-8,15, 22, 29, 43 and 60
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) and Maximum concentration of study drug (Cmax)
次要结局
- Pharmacokinetics profile: AUClast, tmax, t1/2, Vz, and CLtot(Days 1-8,15, 22, 29, 43 and 60)
- Total lymphocyte count(Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60)
- Peripheral lymphocyte subset quantification(Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60)
- Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs), physical examination, pulse oximetry, and incidence of anti-ASKP1240 antibody formation(Up to day 90)
研究者
研究点 (1)
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