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A First-in-Human Single and Multiple Ascending Dose Study of MT-251 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A First-in-Human Single and Multiple Ascending Dose Study of MT-251

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-251 in Healthy Participants

NCT07423299•Mirador Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-251 in Healthy Participants

Detailed Description

This is a first-in-human study of MT-251, a biologic therapeutic. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-251 in healthy participants. The data obtained from this study will inform further development of MT-251.

Eligibility

Age

19 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female participants between 19 and 55 years of age (inclusive) at the time of signing informed consent.
•2. Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, 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 of any prescription drug within 21 days or 5 half-lives (whichever is longer) of study drug administration; or over-the-counter drug within 7 days or 5 half-lives (whichever is longer) of study drug administration.
•6. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
•7. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
•8. Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.

Locations (1)

Mirador Clinical Department

San Diego, California, United States

Key Dates

Start Date

January 23, 2026

Primary Completion Date

March 8, 2027

Completion Date

March 8, 2027

Last Updated

February 25, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Volunteers

Interventions

MT-251

DRUG

Contacts

Toll-Free Number

CONTACT

844-206-4980 clinicaltrials@miradortx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First-in-Human Single and Multiple Ascending Dose Study of MT-251

Inclusion Criteria

Exclusion Criteria

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