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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06874010 | A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia | PHASE1 | RECRUITING | 20 | — | — | Jun 1, 2025 | Mar 1, 2027 | May 18, 2025 | 3 | Australia |
| NCT06772870 | A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants | PHASE1 | NOT YET_RECRUITING | 36 | — | — | Feb 1, 2025 | Dec 1, 2025 | Feb 21, 2025 | 1 | Australia |
To evaluate the safety and tolerability of single ascending doses of DT-216P2 in normal healthy participants by frequency of treatment-emergent adverse events (TEAEs).
| Arm | Type | Description |
|---|---|---|
| DT-216P2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DT-216P2 | DRUG | Active |
| Saline | DRUG | Normal saline solution will be used as placebo control. |
Inclusion Criteria: * Participants must be 18-65 years of age inclusive, at the time of signing the informed consent. * Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in the frataxin gene. * Stage 5.5 or less on the FSA at screening. * BMI between 16 and 32 kg/m2 at sc...