Phase I Study to Evaluate Single and Multiple Oral Doses of HW281171 Tablets in Healthy Participants
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Oral Administration and Dose Escalation of HW281171 Tablets in Healthy Participants
This phase 1 study aims to evaluate the safety, tolerability and pharmacokinetic profiles of HW281171 in healthy Participants. The study consists of three parts: Part A (Single-Dose Escalation Study), Part B (Food Effect and Metabolite Study), and Part C (Multiple-Dose Escalation Study).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前:Lifei Liu
- 電話番号:+86-27-87173753
- メール:liulifei@renfu.com.cn
研究場所
-
-
-
Shanghai、中国
- Huashan Hospital, Fudan University
-
コンタクト:
- Jing Zhang
- 電話番号:+86-21-52887926
- メール:Zhangj_fudan@163.com
-
-
参加基準
適格基準
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:
- Participants sign the informed consent form prior to the initiation of any study procedures.
- Healthy male and female participants aged 18 to 45 years (inclusive), with no less than 3 participants of a single gender.
- Female participants have a body weight of ≥45.00 kg, male participants have a body weight of ≥50.00 kg, and the body mass index (BMI) ranges from 19.0 to 26.0 kg/m^2 (inclusive).
- Participants whose vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, abdominal B-ultrasound and posteroanterior chest X-ray results at screening or on Day -1 are judged by the Investigator to be normal or abnormal without clinical significance.
- Participants agree to have no fertility plan and no sperm/egg donation plan from the time of signing the informed consent form until 3 months after study withdrawal, and are willing to practice abstinence or use highly effective contraceptive methods during this period.
- Participants can communicate well with the Investigator, understand and comply with all requirements of this study, and fully understand the study purpose, nature, methods and potential Adverse Events.
Exclusion Criteria:
- Participants with a history of drug or food allergy, allergic diseases, or allergic diathesis (allergic to two or more substances), or with confirmed allergy to any component or analogue of the investigational product.
- Participants with any past or current clinically significant severe or chronic diseases of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, psychiatric systems or metabolic disorders, or any other diseases judged by the investigator that may interfere with trial results.
- Participants with a history of gastrointestinal, hepatic or renal diseases affecting drug absorption or metabolism, or known or suspected diseases affecting drug intake, transport, absorption, distribution, metabolism or excretion; participants who have undergone surgeries affecting drug absorption or metabolism (appendectomy excluded).
- Participants with abnormal examination results specified in the protocol at screening or on Day -1.
- Participants with a history of drug abuse, drug dependence, or positive drug screening results.
- Participants with positive results for any of human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, or treponema pallidum specific antibody.
- Female participants who are pregnant, lactating at screening or during the trial, or have a pregnancy test result above the upper limit of normal, or have had unprotected sexual intercourse within 2 weeks before screening.
- Participants with prior or concomitant medications/non-drug interventions specified in the protocol.
- Participants who have participated in any clinical trial of drugs or medical devices within 90 days before screening (participation in a clinical trial is defined as receiving or using the investigational drug/device).
- Participants with severe trauma or surgical operation within 3 months before screening; participants who plan to receive surgery during the trial or within two weeks after trial completion.
- Participants who have donated blood or experienced a total blood loss of ≥400 ml within 3 months before the first dose.
- Participants with difficult venous access and intolerance to venipuncture.
- Participants with a smoking history within 3 months before screening (average daily consumption >5 cigarettes), or who cannot stop using any tobacco products during the trial.
- Participants with an average weekly alcohol intake of more than 14 alcohol units within 3 months before screening (1 alcohol unit is approximately 360 ml beer, or 45 ml spirits with 40 Percentage alcohol content, or 150 ml wine), or positive alcohol breath test, or who cannot abstain from alcohol during the trial.
- Participants consuming excessive tea, coffee or caffeinated beverages on average every day (more than 8 cups, 1 cup = 250 ml) within 48 hours before the first dose, or who cannot stop consuming tea, coffee or caffeinated beverages during the trial; participants who have consumed special diets within 48 hours before the first dose (including pitaya, mango, lime, pomelo, carambola, orange, grapefruit or grapefruit products and other fruits or corresponding juices that may affect drug metabolism), or other special diets affecting drug absorption, distribution, metabolism or excretion.
- Participants with special dietary requirements and unable to follow the unified diet.
- Participants with other factors judged by the investigator to be unsuitable for participating in the clinical 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: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:ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:Part A:HW281171
Single dose of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
プラセボコンパレーター:Part A:Placebo
Single dose of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
|
実験的:Part B:Sequence A
Single dose of HW281171 tablets under fasting-fed sequence |
Administered orally daily at pre-specified dose and frequency. |
|
実験的:Part B:Sequence B
Single dose of HW281171 tablets under fed-fasting sequence |
Administered orally daily at pre-specified dose and frequency. |
|
実験的:Part C:HW281171
Multiple doses of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
プラセボコンパレーター:Part C:Placebo
Multiple doses of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The number and severity of treatment emergent adverse events (TEAEs)
時間枠:Up to 1 month
|
To assess the safety and tolerability of single or multiple doses of HW281171 tablets in healthy participants. |
Up to 1 month
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The maximum serum concentration (Cmax)
時間枠:Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
時間枠:Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The time to reach Cmax (Tmax)
時間枠:Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
|
The Half life (t1/2)
時間枠:Up to 1 month
|
Pharmacokinetic parameter |
Up to 1 month
|
協力者と研究者
スポンサー
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- HW281171-101
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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