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NCT Number: NCT07776782

A Single-Dose Study of MT-201 and Concomitant Infliximab in Healthy Participants

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered with Concomitant Infliximab in Healthy Participants

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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, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent.
  • 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.
  • Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential.
  • 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 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.
  • Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
  • Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
  • 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.

Treatment and study plan

MT-201

Drug

MT-201 and Infliximab

Primary outcomes

  1. Number of Participants with non-SAEs and SAES

    Time frame: Up to 8 weeks post dose

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mirador Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered With Concomitant Infliximab in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 21, 2026

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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