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MZE001

Phase 1

Healthy | Small molecule | Other |Maze Therapeutics, Inc.|Last Updated: Feb 6, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

MZE001 · 1 trial · 1 indication

Phase 1 1
NCT05249621A Randomized Phase 1 of of MZE001 in Healthy VolunteersHealthy
COMPLETED121 Analytics
PHASE1COMPLETED
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability of MZE001
14 days

Occurrence of adverse events, serious adverse events, adverse events of special interest

Secondary Endpoints

Maximum concentration following multiple doses of MZE001
14 days
AUC following multiple doses of MZE001
14 days
Accumulation ratio following multiple doses of MZE001
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MZE001EXPERIMENTALMZE001 is a small molecule inhibitor of muscle glycogen synthase for the potential treatment of Pompe disease.
PlaceboPLACEBO_COMPARATORExcipients containing no active ingredients.

Interventions

NameTypeDescription
MZE001DRUGSmall molecule inhibitor of muscle glycogen synthase
PlaceboDRUGProduct containing excipients with no active ingredients
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female subjects, ages 18 - 55 years, inclusive; 2. Must provide written informed consent prior to any study assessments and be willing and able to comply with all study procedures; 3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive; 4. Healthy as determin...

Countries:United States
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Frequently asked questions about MZE001

What is MZE001 used for?

MZE001 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development and has not been approved for any condition. The drug is being evaluated for safety and tolerability in a clinical trial setting.

Who makes MZE001?

MZE001 is being developed by Maze Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical research on this investigational small molecule in the United States.

What phase is MZE001 in?

MZE001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is MZE001 in?

MZE001 was studied in a randomized, double-blind, placebo-controlled Phase 1 trial (NCT05249621) in healthy volunteers. The trial enrolled 121 participants aged 18 years and older in the United States and has been completed.

Is MZE001 FDA approved?

MZE001 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The completed Phase 1 trial was designed to evaluate the drug in healthy volunteers, and it has not progressed to later-stage trials or regulatory approval.