Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects
A Double Blind, Randomized, Single Center, Single and Multiple Dose, Pharmacokinetic, Safety and Tolerability Study of Recombinant Human Alkaline Phosphatase (recAP) Administered Intravenously in Healthy Japanese Subjects
研究概览
地位
条件
详细说明
This study is a randomized, double blind, parallel group, single-center trial, consisting of a single dose part and a multiple dose part in 32 healthy Japanese subjects. Since all these doses have been studied before and safety extensively evaluated in non-Japanese subjects and no ethnic sensitivity is expected, the groups can be dosed in parallel.
Part A will have 3 parallel groups of 8 male subjects with N=6 on active and N=2 on placebo per group. Following baseline assessments, a single dose of recAP will be administered by a one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety assessments.
Part B will have a single group of 8 male subjects with N=6 on active and N=2 on placebo. Following baseline assessments, recAP will be dosed on Days 1, 2 and 3 by one-hour infusions followed by samplings for pharmacokinetic evaluation and routine safety assessments.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
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Tokyo、日本、192-0071
- P-one clinic, Keikokai medical corporation
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Gender : male
- Age : 20-55 years, inclusive
- Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive
- Subjects must be Japanese by birth, have resided outside Japan <10 years, have parents and maternal and paternal grandparents who are Japanese, and primarily consume a Japanese diet.
- Resting supine blood pressure at screening showing no clinically relevant deviations from normal as judged by the Principal Investigator.
- Computerized (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations.
- All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator.
- Ability and willingness to abstain from alcohol and tobacco products from 48 h prior to entry in the clinical research center until discharge.
- Easily accessible veins for venipuncture and catheter placing.
- Willingness to sign the written informed consent form (ICF).
- Subjects must agree to use adequate contraception when sexually active. This applies for the time period between end of first administration and 14 days after the last administration of study drug.
Exclusion Criteria:
- Evidence of clinically relevant pathology.
- History of relevant drug and/or food allergies.
- Subject has a history of clinically significant abnormalities or of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- Use of medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator).
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year.
- Participation in a drug study within 60 days prior to drug administration.
- Donation of more than 500 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 liters of blood (for men) in the 10 months preceding the start of this study
- Smoking more than 5 cigarettes, 1 cigar or 1 pipe daily.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants) and/or alcohol breath test at Screening and/or Pre-Dose.
- Intake of more than 14 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine/Japanese Sake or 35 mL of spirits).
- Positive screen on hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or anti-human immunodeficiency virus (anti-HIV)-1 or anti-HIV-2 or HIV-1/2 antigen.
- Illness within 5 days prior to (the first) drug administration.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo
single 1-hour IV infusion of 0.8 mg/kg recAP or placebo
|
Intravenous infusion
Intravenous infusion
|
有源比较器:Group 2: single 1-hour IV infusion of 1.6 mg/kg recAP or placebo
single 1-hour IV infusion of 1.6 mg/kg recAP or placebo
|
Intravenous infusion
Intravenous infusion
|
有源比较器:Group 3: single 1-hour IV infusion of 3.2 mg/kg recAP or placebo
single 1-hour IV infusion of 3.2 mg/kg recAP or placebo
|
Intravenous infusion
Intravenous infusion
|
有源比较器:Group 4: 1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3
1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3
|
Intravenous infusion
Intravenous infusion
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum observed recAP plasma concentration (Cmax) after single dose
大体时间:Single dose 9 days treatment phase
|
Blood collection for cmax evaluation daily from Day 1 to Day 9
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Single dose 9 days treatment phase
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Time to attain maximum recAP serum concentration (Tmax) after single dose
大体时间:Single dose 9 days treatment phase
|
Blood collection for Tmax evaluation daily from Day 1 to Day 9
|
Single dose 9 days treatment phase
|
Area under the plasma concentration versus time curve (AUC) after single dose
大体时间:Single dose 9 days treatment phase
|
Blood collection for AUC evaluation daily from Day 1 to Day 9
|
Single dose 9 days treatment phase
|
recAP elimination half-life ( t1/2) after single dose
大体时间:Single dose 9 days treatment phase
|
Blood collection for t1/2 evaluation daily from Day 1 to Day 9
|
Single dose 9 days treatment phase
|
Maximum observed recAP plasma concentration (Cmax) after multiple doses
大体时间:Multiple doses 13 days treatment phase
|
Blood collection for cmax evaluation daily from Day 1 to Day 13
|
Multiple doses 13 days treatment phase
|
Time to attain maximum recAP serum concentration (Tmax) after multiple doses
大体时间:Multiple doses 13 days treatment phase
|
Blood collection for Tmax evaluation daily from Day 1 to Day 13
|
Multiple doses 13 days treatment phase
|
Area under the plasma concentration versus time curve (AUC) after multiple doses
大体时间:Multiple doses 13 days treatment phase
|
Blood collection for AUC evaluation daily from Day 1 to Day 13
|
Multiple doses 13 days treatment phase
|
recAP elimination half-life ( t1/2) after multiple doses
大体时间:Multiple doses 13 days treatment phase
|
Blood collection for t1/2 evaluation daily from Day 1 to Day 13
|
Multiple doses 13 days treatment phase
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adverse events (AEs) after single dose
大体时间:Single dose 9 days treatment phase
|
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
|
Single dose 9 days treatment phase
|
Adverse events (AEs) after multiple doses
大体时间:Multiple doses 13 days treatment phase
|
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
|
Multiple doses 13 days treatment phase
|
合作者和调查者
赞助
调查人员
- 研究主任:Annelies Legters、AM-Pharma
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AP-recAP-AKI-01-02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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