First human testing of single and multiple ascending doses of MT-201.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, Phase 1, interventional study gives single and repeated ascending doses of MT-201 or placebo to healthy adult volunteers to characterize safety, tolerability, pharmacokinetics, and immunogenicity. Participants are healthy males or females of nonchildbearing potential aged 19–55 who meet strict screening criteria. Dosing escalates across cohorts to identify dose-related adverse effects and capture PK parameters after single and multiple administrations. Results will be used to define safe dose ranges and guide dosing for later patient trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male participant or female participant of nonchildbearing potential 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 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.
4. Good general health.
5. 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 or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
6. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.

Where it's running

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

Study contacts

• Study coordinator: Toll-Free Number
• Email: clinicaltrials@miradortx.com
• Phone: 844-206-4980

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single-dose MT-201 with Infliximab in healthy adults

  This early phase study tests a single dose of MT-201 given with infliximab in healthy adults to see if it is safe and how the body handles it.

  Recruiting Phase 1 Mirador Therapeutics, Inc. · San Diego, California · NCT07776782

• First-in-human single and multiple ascending dose testing of MT-251 in healthy adults

  This study will test whether MT-251 is safe, well tolerated, and how the body handles it in healthy adults aged 19–55.

  Recruiting Phase 1 Mirador Therapeutics, Inc. · San Diego, California · NCT07423299

• Phase 2 testing of new therapies for moderate-to-severe inflammatory bowel disease

  The study will try two experimental medicines, MT-501 and MT-201, to see if they are safe and help adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 Mirador Therapeutics, Inc. · Birmingham, Alabama and 65 other locations · NCT07113522

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.