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Recruiting

NCT Number: NCT07219368

A First-in-Human Single and Multiple Ascending Dose Study of MT-201

First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.

Recruiting

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mirador Clinical Department, San Diego, California 92121

San Diego, California, 92121, United States

Location status: Recruiting

Location contact

Mirador Clinical Department

CONTACT

[email protected]

844-206-4980

Toll-Free Number

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent.
  • 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.
  • Male participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation.
  • Good general health.
  • Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion criteria

  • History or presence of any clinically significant organ system disease.
  • Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
  • History of alcohol or drug abuse within the past 24 months.
  • Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.
  • Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
  • Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.

Treatment and study plan

MT-201

Drug

MT-201

Placebo

Drug

Placebo

Primary outcomes

  1. Number of Participants with non-SAEs and SAES

    Time frame: Up to 40 weeks

    Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll-Free Number

CONTACT

[email protected]

844-206-4980

Sponsors and collaborators

Lead sponsor

Mirador Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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