A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of BON-107 in Healthy Participants
A Phase 1, Randomized, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BON-107 in Healthy Participants
The purpose of this study is to test if the study drug, BON-107, is safe and tolerable when given on its own in both single (Part A) and multiple doses (Part B) to healthy volunteers. The effect of food on how the study drug is processed in the body (Part C) will also be assessed.
調査の概要
詳細な説明
BON-107 is an experimental drug. This study is the first time BON-107 will be given to humans, and the main goal of the study is to evaluate safety, tolerability, and see how the drug is processed by the body. The study will be in three parts.
Part A: Healthy participants will receive one dose of BON-107 or placebo by mouth. The placebo is a pill that contains no active drug. Participants will not know if they are taking the drug or placebo.
Part B: Healthy participants will receive multiple doses of BON-107 or placebo by mouth. Participants will not know if they are taking the drug or placebo.
Part C: Healthy participants in China will receive BON-107 with or without food to evaluate the effect of food on how the study drug is processed in the body.
This study will enroll approximately 100 healthy adult participants. The overall time to participate in this study will be approximately two months.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Study Director
- 電話番号：8778285568
- メール：clinicaltrials@beonemed.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:
- Healthy participants, defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
- Body Mass Index (BMI) of 18 to 32 kg/m^2; and a total body weight > 50 kg (110 lbs).
- Participants must agree to use contraception.
Exclusion Criteria:
- In the investigator's opinion, evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, dermatologic or allergic disease.
- Any condition possibly affecting drug absorption.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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：順次割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Part A: Single Ascending Doses (SAD) of BON-107
Sequential cohorts of healthy participants will receive a single dose of BON-107 at increasing dose levels. |
Administered orally. |
|
プラセボコンパレーター：Part A: Placebo
Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
Administered orally. |
|
実験的：Part B: Multiple Ascending Doses (MAD) of BON-107
Sequential cohorts of healthy participants will receive multiple doses of BON-107 at increasing dose levels. |
Administered orally. |
|
プラセボコンパレーター：Part B: Placebo
Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
Administered orally. |
|
実験的：Part C: Food Effect of BON-107
Healthy participants will take BON-107 in a fed and fasted state, with a washout period between. |
Administered orally. |
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 |
|---|---|---|
|
Number of Participants with Adverse Events
時間枠：From first dose to 30 days after the last dose of study drug; up to approximately 40 days.
|
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant abnormalities from laboratory tests, vital signs and electrocardiogram results. |
From first dose to 30 days after the last dose of study drug; up to approximately 40 days.
|
|
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Tests
時間枠：From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
|
|
Number of Participants with Clinically Significant Change from Baseline in Vital Signs
時間枠：From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
|
|
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram Cardiac Conduction Intervals
時間枠：From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
Cardiac conduction intervals will be assessed via 12-lead electrocardiogram (ECG). |
From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: AUC from Time Zero to Infinite Time (AUCinf) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: AUC from Time Zero to End of Dosing Interval (AUCtau) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Maximum Observed Plasma Concentration (Cmax) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Time to Maximum Plasma Concentration (Tmax) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Trough Plasma Concentration (Ctrough) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Terminal Half-Life (t1/2) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Apparent Drug Clearance (CL/F) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Parts A and B: Apparent Volume of Distribution (Vz/F) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose.
|
|
Part C: AUC from Time Zero to 24 Hours Postdose (AUC0-24) of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: AUClast of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: AUCinf of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: Cmax of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: Tmax of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: t1/2 of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: CL/F of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
|
Part C: Vz/F of BON-107
時間枠：Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period.
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Study Director、BeOne Medicines
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- BON-107-101
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?
IPD プランの説明
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD 共有時間枠
See plan description
IPD 共有アクセス基準
See plan description
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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