A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of MZE001 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects

Maze Therapeutics1 site in 1 country121 target enrollmentFebruary 7, 2022

ConditionsHealthy

InterventionsMZE001 Placebo

DrugsMZE001 Placebo

Overview

Phase: Phase 1
Intervention: MZE001
Conditions: Healthy
Sponsor: Maze Therapeutics
Enrollment: 121
Locations: 1
Primary Endpoint: Number of participants with adverse events as a measure of safety and tolerability of MZE001
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 7, 2022

End Date

December 21, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Maze Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects, ages 18 - 55 years, inclusive;
•Must provide written informed consent prior to any study assessments and be willing and able to comply with all study procedures;
•Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;
•Healthy as determined by the Investigator based on pre-study medical history, physical examination, and baseline safety laboratory studies.
•Able to complete exercise treadmill test with no cardiac abnormalities detected
•Females of childbearing potential who are sexually active with a non-sterilized partner must use a highly effective method of contraception during study participation and for 30 days after last administration of study drug.
•Males of childbearing potential must use a highly effective method of birth control during study participation and for 90 days after last administration of study drug.

Exclusion Criteria

•Any concurrent condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm;
•Any history of coronary artery disease or cardiovascular disease;
•History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
•History of cancer within past 5 years, with the exception of non-melanoma skin cancer and treated / excised melanoma;
•Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to the Screening visit;
•Fridericia's corrected QT (QTcF) \> 450 ms for male participants and \> 470 ms for female participants or history of QT interval prolongation;
•History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion
•Resting seated blood pressure \< 90/40 mmHg or \> 140/90 mmHg
•Resting seated heart rate \< 45 bpm or \> 99 bpm
•Poor peripheral venous access;