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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Director
- Telefonnummer: 8778285568
- E-post: clinicaltrials@beonemed.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Placebo komparator: Part A: Placebo
Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
Administered orally. |
|
Eksperimentell: 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. |
|
Placebo komparator: Part B: Placebo
Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
Administered orally. |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Director, BeOne Medicines
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- BON-107-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
See plan description
Tilgangskriterier for IPD-deling
See plan description
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
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