Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia
NCT ID: NCT05573698
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2022-09-27
2023-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Multiple Dose: DT-216
Participants will be administered multiple doses of DT-216
DT-216
DT-216 will be administered by intravenous (IV) injection
Multiple Dose: DT-216 matching placebo
Participants will be administered multiple doses of placebo
Placebo
Matching Placebo will be administered by intravenous (IV) injection
Interventions
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DT-216
DT-216 will be administered by intravenous (IV) injection
Placebo
Matching Placebo will be administered by intravenous (IV) injection
Eligibility Criteria
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Inclusion Criteria
* Able and willing to sign informed consent form prior to study enrollment.
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA) at screening.
Exclusion Criteria
* Has clinically significant abnormal laboratory results.
* Has significant cardiac disease.
* Received an investigational drug within 3 months of screening.
18 Years
55 Years
ALL
No
Sponsors
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Design Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinilabs
Eatontown, New Jersey, United States
Countries
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Other Identifiers
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DTX-216-102
Identifier Type: -
Identifier Source: org_study_id
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