A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Liping Ma
- 電話番号:0518-82342973
- メール:liping.ma@hengrui.com
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:
- Able and willing to provide written informed consent and to comply with the study protocol;
- Must be 18 to 45 years of age (inclusive);
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
- Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;
Exclusion Criteria:
- History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
- Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
- Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Suspected allergy to any ingredient in the study drug;
- Use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug;
- Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator;
- Use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug;
- Participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer);
- Receiving vaccine(s) within 1 month prior to the first dose of study drug;
- Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling;
- An average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 3 months before screening;
- Subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up;
- Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet;
- Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- Pregnant or lactating females;
- Other conditions judged by the investigator to be not suitable to participate in the trial;
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Treatment group A(Part A)
Drug1: HRS5685, dose 1; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group B(Part A)
Drug1: HRS5685, dose 2; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group C(Part A)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group D(Part A)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group E(Part A)
Drug1: HRS5685, dose 5; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group F(Part A)
Drug1: HRS5685, dose 6; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group G(Part B)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
実験的:Treatment group H(Part B)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
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 |
|---|---|
|
Safety and tolerability: Incidence and severity of adverse events
時間枠:Up to Day 63 after the last dose
|
Up to Day 63 after the last dose
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Area under the concentration-time curve during a dosing interval (AUCtau),
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Maximum observed concentration (Cmax)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Time to Maximum observed concentration (Tmax)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Half-life (t1/2),
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent clearance (CL/F)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent volume of distribution (Vz/F)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Trough concentration (Ctrough)
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Accumulation ratio (Rac),
時間枠:Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Renal clearance (CLr)
時間枠:Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative amount of drug excreted (Ae)
時間枠:Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative percentage of dose recovered (fe)
時間枠:Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HRS5685-101
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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