Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
New Zealand Clinical Research
Grafton, Aukland, New Zealand
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 10 days of dosing
Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627
Time frame: Up to 10 days of dosing
NEU-627 concentrations
Time frame: Up to 10 days of dosing
Change from baseline of the corrected QT interval
Time frame: Up to 10 days of dosing
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