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DT-216P2 · 2 trials · 1 indication
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...
DT-216P2 is an investigational small molecule being developed for the treatment of Friedreich Ataxia, a rare inherited disease that causes progressive nervous system damage. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
DT-216P2 is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol DSGN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.
DT-216P2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials are listed on ClinicalTrials.gov, one in healthy participants and one in patients with Friedreich Ataxia.
DT-216P2 is being studied in two Phase 1 trials. NCT06772870 is a single ascending dose study in healthy participants, not yet recruiting. NCT06874010 is a multiple ascending dose study in patients with Friedreich Ataxia, currently recruiting. Both trials are being conducted in Australia.
Yes, one of the two Phase 1 trials for DT-216P2, NCT06772870, is a single ascending dose study enrolling healthy participants aged 18 years and older. This study is designed to evaluate the safety and tolerability of the drug in a controlled setting.
The clinical development program for DT-216P2 includes randomized, double-blind, placebo-controlled trials. The multiple ascending dose study in patients with Friedreich Ataxia uses a placebo control, and the trials are designed to be double-blind to reduce bias.