This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.
Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered MZE001 in healthy subjects, in fasted and fed states. Each SAD and MAD cohort will enroll 8 subjects randomized 6 active: 2 placebo to receive single or multiple doses of MZE001.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
121
Orange County Research Center
Tustin, California, United States
Number of participants with adverse events as a measure of safety and tolerability of MZE001
Occurrence of adverse events, serious adverse events, adverse events of special interest
Time frame: 14 days
Maximum concentration following multiple doses of MZE001
PK
Time frame: 14 days
AUC following multiple doses of MZE001
PK
Time frame: 14 days
Accumulation ratio following multiple doses of MZE001
PK
Time frame: 14 days
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