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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
DT-216 will be administered by intravenous (IV) injection
Placebo will be administered by intravenous (IV) injection
Clinilabs
Eatontown, New Jersey, United States
Frequency of treatment adverse events (TEAEs)
Frequency of treatment emergent adverse events (TEAEs)
Time frame: Up to approximately 30 days
Maximum Plasma Concentration (Cmax) of DT-216
Maximum Plasma Concentration (Cmax) of DT-216
Time frame: Up to approximately 30 days
Time to Maximum Plasma Concentration (Tmax) of DT-216
Time to Maximum Plasma Concentration (Tmax) of DT-216
Time frame: Up to approximately 30 days
Area Under the Concentration-time Curve (AUC) of DT-216
Area Under the Concentration-time Curve (AUC) of DT-216
Time frame: Up to approximately 30 days
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