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

NCT ID: NCT06762457

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-11
• Study Completion Date: 2025-05-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part 1 - Single Ascending Dose

To assess the safety and tolerability of single doses of MT-501 following oral administration.

Group Type: EXPERIMENTAL

MT-501

Intervention Type: DRUG

MT-501 Tablets

Part 2 - Multiple Ascending Dose

To assess the safety and tolerability of multiple doses of MT-501 following oral administration.

Group Type: EXPERIMENTAL

MT-501

Intervention Type: DRUG

MT-501 Tablets

Interventions

MT-501

MT-501 Tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent.

2. Females must be of non-childbearing potential and must have undergone sterilization procedures, and have official documentation, at least 6 months prior to the first dose.

3. Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method.

4. Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug.

5. Good general health.

6. Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion Criteria

1. History or presence of any clinically significant organ system disease.

2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.

3. History of alcohol or drug abuse within the past 24 months.

4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.

5. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mirador Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mirador Clinical Department

San Diego, California, United States

Countries

United States

Other Identifiers

IND 174036

Identifier Type: OTHER

Identifier Source: secondary_id

MT-501-101

Identifier Type: -

Identifier Source: org_study_id