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

Description

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.

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

San Diego

Mirador Clinical Department, San Diego, California, United States, 92121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

19 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mirador Therapeutics, Inc.,

Study Record Dates

2025-06