At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
CTI-1601 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia
In Brief
A Phase 1 clinical trial evaluating CTI-1601 and Placebo for Friedreich Ataxia. Completed, enrolled 28 participants across 1 site.
Detailed Summary
To evaluate the safety and tolerability of single ascending doses of CTI-1601 in participants with Friedreich's ataxia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich Ataxia
CountriesUnited States
CollaboratorsVeristat, Inc., Metrum Research Group, LLC
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartDec 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedNov 26, 2019
Enrollment StartDec 11, 2019
Primary CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.6 years ago
Interventions
CTI-1601biological
CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
Placebobiological
Placebo Comparator