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

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

This will test whether single and multiple doses of MT-201 are safe, tolerated, and how the body processes them in healthy adults aged 19–55.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Mirador Therapeutics, Inc. (industry)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT07219368 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 19–55, male or female of nonchildbearing potential, in good general health and able to give informed consent and comply with study procedures.

Not a fit: People with clinically significant organ disease, abnormal labs or ECG judged clinically important, women of childbearing potential, or those outside the age range are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify safe dose ranges and PK behavior that enable later patient trials and development of MT-201 as a therapeutic option.

How similar studies have performed: This is the first-in-human trial for MT-201; while dose-escalation Phase 1 studies of similar biologics have often defined safe dosing, MT-201 itself has not yet been tested in humans.

Eligibility criteria

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 this trial is running

San Diego, California

• Mirador Clinical Department, San Diego, California 92121 — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Toll-Free Number

Conditions: Healthy Volunteer, MT-201, Phase 1