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NCT05573698 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia
A Phase 1 study of Friedreich Ataxia, sponsored by Design Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05573698: Completed Phase 1 study of Friedreich Ataxia, sponsored by Design Therapeutics.
NCT05573698 is a Phase 1 study of Friedreich Ataxia that has completed, run by Design Therapeutics. The registered enrollment target is 32 participants, below the 447-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573698, a Phase 1 study of Friedreich Ataxia, has completed, sponsored by Design Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of multiple doses of intravenous DT-216 in adult patients with Friedrich Ataxia.
Primary Outcome
Frequency of treatment emergent adverse events (TEAEs)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DT-216
Study Locations (1)
New Jersey
- Clinilabs - Eatontown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 1 |
What the finished NCT05573698 record still lists
NCT05573698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 447-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Friedreich Ataxia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05573698 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05573698 about?
NCT05573698 is a clinical study titled "Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of multiple doses of intravenous DT-216 in adult patients with Friedrich Ataxia.
What is the current status of trial NCT05573698?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-09-27. Estimated completion is 2023-08-25.
What conditions does trial NCT05573698 study?
This clinical trial studies the following conditions: Friedreich Ataxia.
What interventions are being tested in trial NCT05573698?
The interventions under investigation include: Placebo (DRUG), DT-216 (DRUG).
Who is sponsoring clinical trial NCT05573698?
This trial is sponsored by Design Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05573698 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05573698's enrollment target sits among peer trials
32 10th of 14 higher than 5 of 14 other Friedreich Ataxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Friedreich Ataxia 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.
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