First-in-human testing of single and multiple ascending doses of MT-701.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-701 in Healthy Participants

This study will test whether single and multiple doses of the experimental biologic MT-701 are safe, tolerated, and how the body processes it in healthy adults aged 19–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Mirador Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT07396909 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, phase 1 trial of MT-701 administered as single and multiple ascending doses to healthy adult volunteers. Participants will be enrolled into dose cohorts that receive escalating amounts of MT-701 with careful safety monitoring and pharmacokinetic blood sampling. The trial will also measure immunogenicity to see if participants develop antibodies against MT-701. Data from safety, tolerability, PK, and immunogenicity will inform dose selection and the design of later patient studies.

Who should consider this trial

Good fit: Healthy adults aged 19–55 in good general health who are able to give informed consent and (for women) are of nonchildbearing potential, with men agreeing to use effective contraception, are the intended participants.

Not a fit: People who are pregnant or of childbearing potential without appropriate contraception, outside the 19–55 age range, or with significant medical conditions, abnormal labs, or recent substance abuse will not qualify and are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If MT-701 is shown to be safe with acceptable pharmacokinetics and low immunogenicity, the results could enable further clinical development that may eventually lead to a new therapeutic option.

How similar studies have performed: The single- and multiple-ascending-dose design is a standard first-in-human approach for biologics and has supported successful development of some therapies, but MT-701 itself has no prior human data.

Eligibility criteria

Inclusion Criteria:

1. Male or female (of non-childbearing potential only) 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 participants 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. 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 of study drug administration; or over-the-counter drug within 7 days 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-701; Phase 1