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A Randomized Phase 1 of of MZE001 in Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Maze Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Summary
This trial tests a new drug called MZE001 to see if it is safe and how it behaves in the body. Healthy volunteers will take the drug in different doses and conditions (with and without food). Researchers will monitor how the drug is absorbed and if there are any side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events as a measure of safety and tolerability of MZE001
Secondary study objectives
AUC following multiple doses of MZE001
Accumulation ratio following multiple doses of MZE001
Maximum concentration following multiple doses of MZE001
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MZE001Experimental Treatment1 Intervention
MZE001 is a small molecule inhibitor of muscle glycogen synthase for the potential treatment of Pompe disease.
Group II: PlaceboPlacebo Group1 Intervention
Excipients containing no active ingredients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MZE001
2022
Completed Phase 1
~130
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Maze TherapeuticsLead Sponsor
Sarah Noonberg, MDStudy DirectorMaze Therapeutics