MZE001 for Healthy Subjects

Phase-Based Progress Estimates
Orange County Research Center, Tustin, CAHealthy SubjectsMZE001 - Drug
18 - 55
All Sexes
What conditions do you have?

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 17 days

14 days
AUC following multiple doses of MZE001
Accumulation ratio following multiple doses of MZE001
Maximum concentration following multiple doses of MZE001
Number of participants with adverse events as a measure of safety and tolerability of MZE001
17 days
PK following multiple doses of MZE001

Trial Safety

Safety Progress

1 of 3

Side Effects for

4%Skin laceration
4%Oedema peripheral
4%Blood pressure increased
1%Atrial fibrillation
1%Abdominal pain upper
1%Inguinal hernia
1%Bronchitis viral
1%Mental status changes
1%Upper respiratory tract infection bacterial
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01176240) in the Droxidopa ARM group. Side effects include: Headache with 13%, Dizziness with 10%, Nausea with 9%, Fatigue with 7%, Hypertension with 6%.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

121 Total Participants · 2 Treatment Groups

Primary Treatment: MZE001 · Has Placebo Group · Phase 1

Experimental Group · 1 Intervention: MZE001 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 17 days

Who is running the clinical trial?

Maze TherapeuticsLead Sponsor
Sarah Noonberg, MDStudy DirectorMaze Therapeutics

Eligibility Criteria

Age 18 - 55 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is this research initiative still accepting new participants?

"According to information available on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. As per the data published on, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.