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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05262023 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) | PHASE1 | ACTIVE NOT_RECRUITING | 85 | — | — | Feb 1, 2022 | Nov 1, 2028 | Jan 15, 2026 | 26 | United States, Belgium +10 |
| Arm | Type | Description |
|---|---|---|
| DNL593 (Healthy Participant) | EXPERIMENTAL | - |
| Placebo (Healthy Participant) | PLACEBO_COMPARATOR | - |
| DNL593 (Participants with FTD) | EXPERIMENTAL | - |
| Placebo (Participants with FTD) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DNL593 | DRUG | Ascending single doses (for healthy participants) and multiple doses (for participants with FTD) |
| Placebo | DRUG | Ascending single doses (for healthy participants) and multiple doses (for participants with FTD) |
Key Inclusion Criteria: Part A: * Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 55 years * BMI of ≥ 18 to ≤ 32 kg/m² * When engaging in sex with a woman of child bearing potential, two forms of birth control are required Part B: * Women of n...