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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-251 in Healthy Participants

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

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Mirador Therapeutics, Inc. (industry)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT07423299 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 trial will give single and multiple ascending doses of MT-251 to healthy volunteers to characterize safety, tolerability, pharmacokinetics, and immunogenicity. Participants will be randomized to receive MT-251 or placebo and will undergo serial clinical assessments, lab testing, ECGs, and blood sampling for PK and antibody responses. Dose escalation decisions will be based on safety and tolerability data from earlier cohorts. The results will guide dose selection and design for subsequent patient trials.

Who should consider this trial

Good fit: Healthy adults 19–55 years old who are non-smokers, in good general health, females of nonchildbearing potential or surgically sterile, and able to comply with study procedures are ideal candidates.

Not a fit: People with clinically significant organ disease, abnormal labs or ECG, smokers, pregnant or childbearing-capable females, or those outside the age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If MT-251 is shown to be safe and well tolerated, the data could enable later patient trials to test whether the drug is effective for its intended indications.

How similar studies have performed: Other first-in-human single- and multiple-ascending-dose studies of biologic therapeutics have commonly established safe dose ranges and PK profiles, though efficacy must be demonstrated in later trials.

Eligibility criteria

Inclusion Criteria:

1. Male or female participants 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 subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method.
4. Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug.
5. Good general health.
6. 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 this trial is running

San Diego, California

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

Study contacts

• Study coordinator: Toll-Free Number

Conditions: Healthy Volunteers, MT-251, Phase 1