Single-dose MT-201 with Infliximab in healthy adults

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 Phase 1, open-label study will administer a single dose of MT-201 to healthy adult participants who also receive infliximab. The trial will monitor safety, tolerability, pharmacokinetics, and immunogenicity to understand how the drug behaves in the body and whether it triggers an immune response. It is conducted at the Mirador Clinical Department in San Diego and includes strict eligibility criteria to ensure participants are healthy and compliant. Enrollment is limited to adults aged 19 to 55 who meet non-childbearing and health requirements.

Why it matters

Who can join: the full rules

Inclusion 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.
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 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.

Where it's running

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

Study contacts

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

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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.