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

Last updated: January 7, 2025
Sponsor: Mirador Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

MT-501

Clinical Study ID

NCT06762457
MT-501-101
IND 174036
  • Ages 19-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Females must be of non-childbearing potential and must have undergone sterilizationprocedures, and have official documentation, at least 6 months prior to the firstdose.

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

  4. Continuous non-smoker who has not used tobacco or nicotine-containing products forat 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 therequirements of the study.

Exclusion

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 thatis 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 3months prior to screening.

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

Study Design

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: MT-501
Phase: 1
Study Start date:
December 11, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Mirador Clinical Department

    San Diego, California 92121
    United States

    Active - Recruiting

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