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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Director
- 전화번호: 8778285568
- 이메일: clinicaltrials@beonemed.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
위약 비교기: Part A: Placebo
Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
Administered orally. |
|
실험적: 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. |
|
위약 비교기: Part B: Placebo
Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
Administered orally. |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Adverse Events
기간: 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
기간: 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
기간: 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
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
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Parts A and B: Apparent Drug Clearance (CL/F) of BON-107
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Study Director, BeOne Medicines
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BON-107-101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
See plan description
IPD 공유 액세스 기준
See plan description
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
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