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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Tokyo、日本、192-0071
- P-one clinic, Keikokai medical corporation
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:順次割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ: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
|
アクティブコンパレータ: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
|
アクティブコンパレータ: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
|
アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Maximum observed recAP plasma concentration (Cmax) after single dose
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Adverse events (AEs) after single dose
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Annelies Legters、AM-Pharma
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- AP-recAP-AKI-01-02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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