A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of BON-107 in Healthy Participants
NCT07934069, Phase 1, Not yet recruiting, BeOne Medicines
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of BON-107 in Healthy Participants | ClinicalTrials.gov |
| NCT number | NCT07934069 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | BeOne Medicines | ClinicalTrials.gov |
| Conditions | Healthy Participants | ClinicalTrials.gov |
| Interventions | BON-107, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants with Adverse Events | 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. | ClinicalTrials.gov |
| Primary | Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Tests | From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days. | ClinicalTrials.gov | |
| Primary | Number of Participants with Clinically Significant Change from Baseline in Vital Signs | From first dose to up to 30 days after the last dose of study drug; up to approximately 40 days. | ClinicalTrials.gov | |
| Primary | Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram Cardiac Conduction Intervals | 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). | ClinicalTrials.gov |
| Secondary | Parts A and B: Area Under the Concentration Time Curve (AUC) from Time Zero to Last Quantifiable Time (AUClast) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: AUC from Time Zero to Infinite Time (AUCinf) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: AUC from Time Zero to End of Dosing Interval (AUCtau) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Maximum Observed Plasma Concentration (Cmax) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Time to Maximum Plasma Concentration (Tmax) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Trough Plasma Concentration (Ctrough) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Terminal Half-Life (t1/2) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Apparent Drug Clearance (CL/F) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Parts A and B: Apparent Volume of Distribution (Vz/F) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after the first or last dose. | ClinicalTrials.gov | |
| Secondary | Part C: AUC from Time Zero to 24 Hours Postdose (AUC0-24) of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: AUClast of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: AUCinf of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: Cmax of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: Tmax of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: t1/2 of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov | |
| Secondary | Part C: CL/F of BON-107 | Blood samples will be taken predose and postdose at select time points, up to 7 days after dosing in each period. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)