Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BON-107 · 1 trial · 1 indication
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.
Cardiac conduction intervals will be assessed via 12-lead electrocardiogram (ECG).
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Doses (SAD) of BON-107 | EXPERIMENTAL | Sequential cohorts of healthy participants will receive a single dose of BON-107 at increasing dose levels. |
| Part A: Placebo | PLACEBO_COMPARATOR | Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
| Part B: Multiple Ascending Doses (MAD) of BON-107 | EXPERIMENTAL | Sequential cohorts of healthy participants will receive multiple doses of BON-107 at increasing dose levels. |
| Part B: Placebo | PLACEBO_COMPARATOR | Sequential cohorts of healthy participants will receive multiple doses of matching placebo. |
| Part C: Food Effect of BON-107 | EXPERIMENTAL | Healthy participants will take BON-107 in a fed and fasted state, with a washout period between. |
| Name | Type | Description |
|---|---|---|
| BON-107 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
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\...