Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT-600 · 1 trial · 1 indication
Number of Treatment-Emergent Adverse Events.
| Arm | Type | Description |
|---|---|---|
| 5mg SAD | ACTIVE_COMPARATOR | - |
| 5mg SAD placebo | PLACEBO_COMPARATOR | - |
| 10mg SAD | ACTIVE_COMPARATOR | - |
| 10mg SAD placebo | PLACEBO_COMPARATOR | - |
| 5mg MAD | ACTIVE_COMPARATOR | - |
| 5mg MAD placebo | PLACEBO_COMPARATOR | - |
| 10mg MAD | ACTIVE_COMPARATOR | - |
| 10mg MAD placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BT-600 | COMBINATION_PRODUCT | NaviCap device containing liquid formulation of Tofacitinib |
| BT-600 Placebo | COMBINATION_PRODUCT | NaviCap device containing placebo formulation |
Inclusion Criteria: * Healthy, adult male or female, 19-50 years of age. * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the Investigator or designee. * Laboratory results within normal range or not clinical...