A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
2022年2月13日 更新者：Ark Biosciences Inc.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.
調査の概要
詳細な説明
Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.
The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.
研究の種類
介入
入学 (実際)
24
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
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New Jersey
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Secaucus、New Jersey、アメリカ、07094
- Frontage
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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
全て
説明
Inclusion Criteria:
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
- Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.
Exclusion Criteria:
- Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Poor venous access;
- Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
- Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.
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：ヘルスサービス研究
- 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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アクティブコンパレータ：ziresovir
The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
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Planned treatments are:
他の名前：
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プラセボコンパレーター：placebo
The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
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Planned treatments are:
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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 |
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numbers of all AEs
時間枠：through study completion, an average of 22 days
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The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
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through study completion, an average of 22 days
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percentages of all AEs
時間枠：through study completion, an average of 22 days
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The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
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through study completion, an average of 22 days
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change from baseline in systolic and diastolic blood pressure
時間枠：screen/day -1/day 1/day 2/day 3/day4
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blood pressure in millimeter of mercury
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in pulse rate
時間枠：screen/day -1/day 1/day 2/day 3/day4
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pulse rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in respiratory rate
時間枠：screen/day -1/day 1/day 2/day 3/day4
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respiratory rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in oral temperature
時間枠：screen/day -1/day 1/day 2/day 3/day4
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oral temperature in degree
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in Prothrombin time/International Normalized Ratio
時間枠：screen/day -1/day 2/day4
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INR is calculated from the PT and allows for worldwide standardization of results.
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screen/day -1/day 2/day4
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change from baseline in Thrombin time
時間枠：screen/day -1/day 2/day4
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Thrombin time in seconds
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screen/day -1/day 2/day4
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change from baseline in activated Partial Thromboplastin time
時間枠：screen/day -1/day 2/day4
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activated Partial Thromboplastin time in seconds
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screen/day -1/day 2/day4
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change from baseline in Hemoglobin (Hgb) count
時間枠：screen/day -1/day 2/day4
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Hemoglobin (Hgb) in gram per liter
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screen/day -1/day 2/day4
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change from baseline in Hematocrit (Hct)
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Platelet count
時間枠：screen/day -1/day 2/day4
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Platelet count per liter
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screen/day -1/day 2/day4
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change from baseline in Red blood cell (RBC) count
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in White blood cell (WBC) count with differential
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Specific gravity from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in pH from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Protein from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Glucose from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Ketones from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Bilirubin from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Blood from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Nitrites from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Leukocytes from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Urobilinogen from urinalysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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Incidence of abnormal Microscopic urine analysis
時間枠：screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
時間枠：screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in heart rate from resting 12-lead ECGs
時間枠：screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in QRS intervals from resting 12-lead ECGs
時間枠：screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
時間枠：screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in appearance of U-waves from resting 12-lead ECGs
時間枠：screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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Incidence of abnormal physical findings
時間枠：screen/day -1/day2/day3/day4
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full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
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screen/day -1/day2/day3/day4
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二次結果の測定
結果測定 |
時間枠 |
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To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
時間枠：0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
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0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
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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
捜査官
- スタディディレクター：Jimmy Gu、Ark Biosciences
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)
2021年3月24日
一次修了 (実際)
2021年6月14日
研究の完了 (実際)
2021年7月22日
試験登録日
最初に提出
2021年2月1日
QC基準を満たした最初の提出物
2021年3月4日
最初の投稿 (実際)
2021年3月9日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月15日
QC基準を満たした最後の更新が送信されました
2022年2月13日
最終確認日
2022年2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。