Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958
CS-8958 - A Phase I, Double-blind, Placebo-controlled, Ascending, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects.
調査の概要
詳細な説明
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups.Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Control of human influenza virus infections continues to be a major public health goal.Influenza infects the respiratory tract with a rapid onset of symptoms typically characterized by fever, chills, myalgia, headache, malaise, sore throat and cough. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. It is the objective of this clinical trial to investigate safety and tolerability of multiple doses of CS-8958 administered via inhalation in healthy adult subjects. The pharmacokinetics required for this dosing regimen is only achievable by inhalation delivery. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. The primary objective is to evaluate the safety and tolerability of 40mg CS-8958 once or twice a week (on consecutive days) for 6 weeks in healthy adult subjects after multiple doses administered via inhalation. The secondary objective is to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single and multiple doses of CS-8958 in healthy adult subjects.
Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication, once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks.
Adverse events will be recorded at every visit. Vital signs including blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin will be measured on admission, pre-dose and at multiple time points post each dose. ECGs will be performed on admission, pre-dose and at multiple time points post each dose.Continuous cardiac telemetry will be performed for 24 hours post first dose each week for cohort A and 60 hours post first dose each week for cohort B. Spirometry assessments including forced vital capacity, forced expiratory volume in 1 second, forced expiratory volume percentage in 1 second, forced expiratory flow rate, and peak expiratory flow rate will be performed on admission, pre-dose and at multiple time points post dose. Physical examinations will be performed on Day -1 and at the final visit (and as needed if subject develops symptomatology). Blood samples for hematology and biochemistry assessments will be taken on admission, and 24 hours post dose each week. Urine samples for urinalysis tests will be collected on admission, and 24 hours post dose each week. Blood samples for pharmacokinetic testing will be taken pre-dose and at multiple time points post each dose.
The Safety Monitoring Committee (SMC) will review the safety, tolerability and pharmacokinetic data from Cohort A prior to beginning Cohort B.
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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Leeds、イギリス
- Covance Clinical Research Unit Limited
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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:
- Male and Female subjects aged 18 to 55 years, inclusive
Exclusion Criteria:
- Pregnant or lactating female subjects.
- Out of range findings in vital signs, physical examination, or lab tests.
- Intake of any investigational drug within the 4 months prior to Day 0.
- Positive urine drug screen or alcohol breath test.
- Significant disease, event, or condition which may impact on subject safety or study compliance.
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:4倍
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:プラセボ
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Inhaled placebo
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実験的:CS-8958 DPI
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Inhaled CS-8958
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 |
時間枠 |
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Safety and tolerability will be assessed via occurrences of treatment-emergent adverse events, changes in vital signs including BP, PR, SpO2, temperature, ECG, spirometry, physical examinations, and laboratory parameters
時間枠:Duration of study
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Duration of study
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協力者と研究者
捜査官
- 主任研究者:Jane Ryan, PhD、Biota Scientific Management Pty Ltd
研究記録日
主要日程の研究
研究開始
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
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。
Placeboの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico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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University Hospital, Strasbourg, France積極的、募集していない