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NCT05285540 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia
A Phase 1 study, sponsored by Design Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT05285540: Completed Phase 1 study, sponsored by Design Therapeutics.
NCT05285540 is a Phase 1 study that has completed, run by Design Therapeutics. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05285540, a Phase 1 study, has completed, sponsored by Design Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.
Primary Outcome
Frequency of treatment emergent adverse events (TEAEs)
Interventions
- DRUG DT-216
- DRUG DT-216 matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2022-12-19 |
| Phase | Phase 1 |
What the finished NCT05285540 record still lists
NCT05285540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which DT-216 is the first listed.
NCT05285540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05285540 about?
NCT05285540 is a clinical study titled "Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.
What is the current status of trial NCT05285540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2022-03-11. Estimated completion is 2022-12-19.
What interventions are being tested in trial NCT05285540?
The interventions under investigation include: DT-216 (DRUG), DT-216 matching Placebo (DRUG).
Who is sponsoring clinical trial NCT05285540?
This trial is sponsored by Design Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05285540's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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