A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
2014年9月29日 更新者：Janssen Research & Development, LLC
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
調査の概要
状態
完了
条件
詳細な説明
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men.
Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion.
The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center).
During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo.
Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157.
Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level.
The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner.
An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B).
Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo.
Only Caucasian participants will be enrolled in the IV treatment group (group 4).
For each treatment group, blood and urine samples will be taken at various time points during the study.
Each participant will take part in the study for approximately 85 days.
Participant safety will be monitored throughout the study.
研究の種類
介入
入学 (実際)
40
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Cypress、California、アメリカ
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Exclusion Criteria:
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1A
100 mg CNTO 3157 or placebo in healthy male Japanese participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
実験的：Group 1B
100 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
|
|
実験的：Group 2A
300 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
実験的：Group 2B
300 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
|
実験的：Group 3A
600 mg CNTO 3157 or placebo in healthy male Japanese participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
実験的：Group 3B
600 mg CNTO 3157 or placebo in healthy male Caucasian participants
|
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
4 SC injections of CNTO 3157 providing a total dose of 600 mg
|
|
実験的：Group 4
300 mg CNTO 3157 in healthy male Caucasian participants
|
2 SC injections of CNTO 3157 providing a total dose of 300 mg
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
|
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 |
|---|---|---|
|
Frequency of adverse events
時間枠：Up to Day 57
|
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
|
Up to Day 57
|
|
Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
時間枠：Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
時間枠：Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
時間枠：Up to Day 57
|
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
|
Up to Day 57
|
|
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
時間枠：Up to Day 57
|
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
|
Up to Day 57
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年12月1日
一次修了 (実際)
2014年8月1日
研究の完了 (実際)
2014年8月1日
試験登録日
最初に提出
2013年12月6日
QC基準を満たした最初の提出物
2013年12月6日
最初の投稿 (見積もり)
2013年12月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月30日
QC基準を満たした最後の更新が送信されました
2014年9月29日
最終確認日
2014年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
100 mg CNTO 3157の臨床試験
-
Centocor Research & Development, Inc.完了全身性エリテマトーデス | エリテマトーデス、皮膚
-
Hospices Civils de LyonGlaxoSmithKline募集
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.完了
-
Johnson & Johnson Pharmaceutical Research & Development...引きこもった
-
DSM Nutritional Products, Inc.完了