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MZE001 for Healthy Subjects

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
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective. It is a Phase 1 trial, which means it is the first time the drug is being tested in humans. The trial is double-blind, which means that neither the participants nor the researchers will know who is receiving the drug and who is receiving the placebo. The trial will also test to see if the drug works better when taken with food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability of MZE001
Secondary outcome measures
AUC following multiple doses of MZE001
Accumulation ratio following multiple doses of MZE001
Maximum concentration following multiple doses of MZE001

Side effects data

From 2012 Phase 3 trial • 225 Patients • NCT01176240
13%
Headache
10%
Dizziness
9%
Nausea
7%
Fatigue
6%
Hypertension
5%
Contusion
5%
Excoriation
4%
Skin laceration
4%
Diarrhoea
4%
Oedema peripheral
4%
Blood pressure increased
1%
Abdominal pain upper
1%
Faecaloma
1%
Inguinal hernia
1%
Atrial fibrillation
1%
Bronchitis viral
1%
Upper respiratory tract infection bacterial
1%
Presyncope
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Droxidopa

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors being included in the current research protocol?

"This trial necessitates that potential participants fall within the age range of 18 to 55. For those under 18 and over 65, there are 50 studies respectively available for them."

Answered by AI

Is it possible for me to participate in this clinical research project?

"This clinical trial desires 104 participants ranging from 18 to 55 years. In order for an individual to take part, they must be willing and able comply with the study's procedures; have a BMI of between 18.0 and 32.0 kg/m2 inclusive; females should undertake highly effective contraception during their participation in the research as well as 30 days after their final dose, while males need to use birth control for 90 days afterwards; demonstrate healthiness according to medical history, physical examination, laboratory studies results and complete exercise treadmill test without cardiac abnormalities."

Answered by AI

Is this research initiative still accepting new participants?

"According to information available on clinicaltrials.gov, this medical trial is currently open for recruitment and was initially posted on February 7th 2022 with a recent update recorded as of August 31st 2022."

Answered by AI

Does the FDA recognize MZE001 as an approved drug?

"The safety of MZE001 is rated a 1 since this is an early-stage clinical trial. This means that the available evidence supporting its efficacy and safety is limited."

Answered by AI

How many individuals have consented to be part of this research endeavor?

"Affirmative. As per the data published on clinicaltrials.gov, this study is still searching for participants to partake in their research having been initially posted on February 7th 2022 and most recently updated August 31st 2022. 104 volunteers are needed from a single medical site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
2022. "A Randomized Phase 1 of of MZE001 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05249621.
~38 spots leftby Apr 2025
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