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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Study Director
- Numéro de téléphone: 8778285568
- E-mail: clinicaltrials@beonemed.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur placebo: Part A: Placebo
Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
Administered orally. |
|
Expérimental: 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. |
|
Comparateur placebo: Part B: Placebo
Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
Administered orally. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Study Director, BeOne Medicines
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BON-107-101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage IPD
See plan description
Critères d'accès au partage IPD
See plan description
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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