A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
A Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy Subjects
調査の概要
詳細な説明
This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.
The study observed blood concentrations of the experimental drug at different time points after and before administration, TNFα before and after treatment at different time points will be observed as well.
C-T curve will be drawn with blood drug concentration (c) and time (T) in the trial. At the same time, the investigators will draw the average plasma concentration curve. Compartmental and non compartmental model will be used to analyze the pharmacokinetic parameters of subjects. It will be judged with linear or nonlinear elimination by the correlation analysis of AUC, Cmax of different doses. In the meantime, adverse events, vital signs, physical examination, laboratory examination and ECG will be evaluated.
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
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Beijing
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Beijing、Beijing、中国、100044
- Peking University People's Hospital
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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:
- healthy adult volunteers who are voluntary to participate in clinical trials, and signed the informed consent
- aged 18-45 years, the same batch of subjects age difference is less than or equal to 10 years of age
- subjects with qualified physical examination within 7 days before the trial, body mass index (BMI) from19 to 24 ,and the same batch of subjects are with the similar weight
- the basic indicators of heart, liver, kidney and blood examination are in the normal range.
Exclusion Criteria:
- subjects are during the acute or chronic infection period, or have a previous history of active tuberculosis
- subjects are with the history of diseases of the central nervous system, cardiovascular system, kidney, liver (specific indexes of liver function), digestive system ,respiratory system or metabolic system or suffered from other significant disease
- subjects as allergic constitution after inquiry, suspected or confirmed or have a history of drug, food allergy , or subjects with a clear history of allergies and / or allergic to the humanized TNF alpha monoclonal antibody or the ingredient of humanized TNF alpha monoclonal antibody , or serum immunoglobulin E (IgE) examination was abnormal
- subjects are included in other clinical trials of other drugs 3 months before being enrolled in this clinical trial, or candidates used drugs known to have damage to the main organs within 3 months before this trial;
- candidates with blood donation history 3 months before being enrolled
- Prescription and non prescription drugs were administrated Within 2 weeks before inclusion
- ALT or AST > 1.5N (the upper limit of normal), Cr>N (the upper limit of normal);
- leukocyte absolute value less than 3.50 × 109/L or > 9.50× 109/L, neutrophil absolute value less than 1.8× 109/L, platelet counts less than 100 × 109/L, hemoglobin is less than 100g/L
- hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome (Anti-HIV) antibody and anti Treponema pallidum antibody (TP-Ab) are positive subjects
- candidates with positive tuberculin skin test with 5 unit dose tuberculin , the size of 48-72 hour scleroma greater than 5 mm
- subjects with positive anti nuclear antibodies (ANA, ds-DNA, ENA)
- subjects with positive resistantance antibody
- subjects had a history of mental illness
- subjects who are pregnant, lactating women or a planning pregnant within 3 months
- subjects with the history of orthostatic hypotension
- with drug or drug abuse history after inquiry
- daily smoking more than 5 cigarettes or the same amount of tobacco after inquiry
- subjects drink more than 28 units of alcohol after inquiry, or alcohol breath test are positive within 24 hours before the acceptance of the tested drugs
- There is a family history of cancer
- Significantly abnormal values in clinical appeared during the screening
- subjects cannot understand, exchangeand cooperate enough, and cannot guarantee the researchers according to the scheme
- researchers don't think it is right to participate in the research with other reasons.
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:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:Placebo group
The arm is as a control group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.
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Subcutaneous injection of different doses for healthy people
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実験的:experimental group
The arm is as an experimental group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.
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Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people
他の名前:
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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 |
---|---|---|
AUC
時間枠:28 days
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AUC
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28 days
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Cmax
時間枠:28 days
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Cmax
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28 days
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Cmin
時間枠:28 days
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Cmin
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28 days
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Tmax
時間枠:28 days
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Tmax
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28 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Serum creatinine and AST and ALT
時間枠:28 days
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Serum creatinine and AST and ALT
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28 days
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or any other adverse events
時間枠:28 days
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or any other adverse events
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28 days
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協力者と研究者
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 (見積もり)
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
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placeboの臨床試験
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Palacky University完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない