At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 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 2, Randomized, Double-Blind, Placebo-Controlled, Dose Exploration Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 in Adult Subjects With Friedreich's Ataxia
In Brief
A Phase 2 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, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration of CTI-1601 over 28 days in subjects with Friedreich's ataxia (FRDA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich Ataxia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartSep 2022
First PostedOct 2022
Primary CompletionDec 2023
TodayJul 2026
First PostedOct 14, 2022
Enrollment StartSep 21, 2022
Primary CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.7 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
Placeboother
Placebo Comparator