A Phase 1 interventional study of MZE001 and Placebo in Healthy, sponsored by Maze Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Maze Therapeutics · Phase 1, Interventional, and Treatment
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.
Maze Therapeutics is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MZE001 is a small molecule inhibitor of muscle glycogen synthase for the potential treatment of Pompe disease.
Drug: MZE001
Excipients containing no active ingredients.
Drug: Placebo
Small molecule inhibitor of muscle glycogen synthase
Also known as: MZ1449348
Product containing excipients with no active ingredients
Also known as: mannitol, silicified microcrystalline cellulose, magnesium stearate
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maze Therapeutics