Ireland
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Recruiting Phase 1

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

NCT07423299 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-01-23
Last updated
2026-02-25

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

MT-251

MT-251: MT-251

Study 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

Eligibility

Sex
ALL
Min age
19 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Number of Subjects with non-SAEs and SAES — Up to 14 days post dose.
    Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.

Trial sites (1)

FacilityCityRegionStatus
Mirador Clinical Department San Diego California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07423299 on ClinicalTrials.gov ↗ ← All trials in the USA