NCT06762457

A First-in-Human Single and Multiple Ascending Dose Study of MT-501

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of MT-501 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Mirador Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of MT-501 in Healthy Adults.

Detailed description

This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of up to 8 days of MT-501 in HV. The safety, tolerability, PK, and PD data obtained from this study will inform further development of MT-501.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MT-501	MT-501 Tablets

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2025-01-07
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study