NCT05249621

A Randomized Phase 1 of of MZE001 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Maze Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MZE001	Small molecule inhibitor of muscle glycogen synthase
DRUG	Placebo	Product containing excipients with no active ingredients

Timeline

• Start date: 2022-02-07
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2022-02-21
• Last updated: 2023-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study