Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06206811 | Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants | PHASE1 | COMPLETED | 101 | — | — | Feb 12, 2024 | Nov 25, 2024 | Feb 21, 2025 | 1 | Australia |
reported SAEs and AEs
| Arm | Type | Description |
|---|---|---|
| Part 1 - Single Ascending dose | EXPERIMENTAL | To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule |
| Part 2 - Multiple Ascending dose | EXPERIMENTAL | To assess the safety and tolerability of multiple ascending doses of OD-07656 administered as an oral capsule |
| Part 3 - Food effect and relative bioavailability between dose forms | EXPERIMENTAL | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet |
| Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 | EXPERIMENTAL | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet following administration of midazolam |
| Name | Type | Description |
|---|---|---|
| OD-07656 | DRUG | innate immune modulator |
Inclusion Criteria: 1. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 2. Body Mass Index (BMI) within the range 18-32kg/m2 (inclusive) 3. Female participants must be of nonchildbeari...