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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Clinilabs
Eatontown, New Jersey, United States
Safety Measure
Frequency of treatment emergent adverse events (TEAEs)
Time frame: Up to approximately 60 days
Pharmacokinetic parameters
Maximum Plasma Concentration (Cmax) of DT-216
Time frame: Up to approximately 60 days
Pharmacokinetic parameters
Time to Maximum Plasma Concentration (Tmax) of DT-216
Time frame: Up to approximately 60 days
Pharmacokinetic parameters
Area Under the Concentration-time Curve (AUC) of DT-216
Time frame: Up to approximately 60 days
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