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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Study Director
- Numer telefonu: 8778285568
- E-mail: clinicaltrials@beonemed.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Komparator placebo: Part A: Placebo
Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
Administered orally. |
|
Eksperymentalny: 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. |
|
Komparator placebo: Part B: Placebo
Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
Administered orally. |
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants with Adverse Events
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Study Director, BeOne Medicines
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- BON-107-101
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
See plan description
Kryteria dostępu do udostępniania IPD
See plan description
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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