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A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

2017年5月12日 更新者：GlaxoSmithKline

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

54

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

  • イギリス
    • Middlesex
      • Harrow、Middlesex、イギリス、HA13UJ
        • GSK Investigational Site

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～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day

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：単一グループの割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Part 1: Cohort 1a
Single IV dose of GSK2862277 as a continuous infusion over 2 hours.
薬：Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
実験的：Part 1: Cohort 1b
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
薬：Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
実験的：Part 1: Cohort 1c
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
薬：Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
実験的：Part 2: Cohort 2a GSK2862277
Single IV dose of GSK2862277 as a continuous infusion over 1 hour.
薬：Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
実験的：Part 2: Cohort 2a Placebo
Matching placebo will be administered as a continuous IV infusion over 1 hour.
薬：Matching placebo single dose IV infusion
Matching placebo solution available for IV administration.
実験的：Part 2: Cohort 2b GSK2862277
Single IH dose of GSK2862277.
薬：Single IH dose of GSK2862277
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
実験的：Part 2: Cohort 2b Placebo
Matching placebo will be administered.
薬：Matching placebo single dose IH
Matching placebo nebulised solution available for IH administration.
実験的：Part 3: Cohort 3a GSK2862277
IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days.
薬：Repeat IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
実験的：Part 3: Cohort 3a Placebo
Matching placebo will be administered as IV infusion over 1 hour daily for 5 days.
薬：Matching placebo repeat dose IV infusion
Matching placebo solution available for IV administration.
実験的：Part 3: Cohort 3b GSK2862277
Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days.
薬：Repeat IH dose selected of GSK2862277 from Part 2
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
実験的：Part 3: Cohort 3b Placebo
Matching placebo will be administered as IH daily for 5 days.
薬：Matching placebo repeat dose IH
Matching placebo nebulised solution available for IH administration.

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
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2
時間枠：Up to 42 days
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3
時間枠：Up to 42 days
Safety and tolerability parameters will include recording of AEs, throughout the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2
時間枠：Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3
時間枠：Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2
時間枠：Up to 42 days
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3
時間枠：Up to 42 days
Vital signs will include BP, heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2
時間枠：Up to 42 days
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3
時間枠：Up to 42 days
Safety data will include ECG readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2
時間枠：Up to 42 days
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3
時間枠：Up to 42 days
Spirometry monitoring will include FEV1 and FVC.
Up to 42 days
Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1
時間枠：Up to 42 days
Blood samples will be collected for assessment of plasma cytokines.
Up to 42 days
Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
時間枠：Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days
Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3
時間枠：Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
時間枠：Up to 48 hours post dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post dose
PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a
時間枠：Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post last dose
PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b
時間枠：Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277
Up to 48 hours post last dose
PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1
時間枠：Up to 48 hours post last dose
The PK parameters will be compared with historic GSK1995057 PK data in Part 1
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
時間枠：Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3
時間枠：Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c
時間枠：Up to 12 hours post dose
IL-8 expression in ex vivo whole blood essay (WBA).
Up to 12 hours post dose
Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a
時間枠：Up to 48 hours post dose
The urine samples will be collected for urine concentrations of GSK2862277.
Up to 48 hours post dose

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。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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 (実際)

2013年2月22日

一次修了 (実際)

2013年10月25日

研究の完了 (実際)

2013年10月25日

試験登録日

最初に提出

2013年2月14日

QC基準を満たした最初の提出物

2013年3月21日

最初の投稿 (見積もり)

2013年3月26日

学習記録の更新

投稿された最後の更新 (実際)

2017年5月15日

QC基準を満たした最後の更新が送信されました

2017年5月12日

最終確認日

2017年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 116343

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?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. データセット仕様
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 個人参加者データセット
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 臨床研究報告書
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 注釈付き症例報告書
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. インフォームド コンセント フォーム
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 統計分析計画
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究プロトコル
    情報識別子：116343
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

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。

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