Actively Recruiting
Phase 1 Study to Evaluate Safety and Effects of Single and Multiple Doses of MT-251 in Healthy Adults Aged 19 to 55
Led by Mirador Therapeutics, Inc. · Updated on 2026-02-25
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying MT-251, a new biologic drug, in healthy adults aged 19 to 55 to evaluate its safety, tolerability, how the body processes it, and its immune response. This Phase 1, randomized, double-blind, placebo-controlled trial aims to gather important information to guide further development of MT-251. Participants will receive either single or multiple doses of MT-251 given by intravenous or subcutaneous injection. The study has two parts one to assess single ascending doses and another to assess multiple ascending doses, both closely monitored to evaluate safety and tolerability. During the study, participants will be monitored for side effects up to 14 days after dosing. Researchers will conduct health assessments and collect data to understand how MT-251 behaves in the body and its impact on the immune system. The study involves healthy volunteers and includes careful follow-up to ensure participant safety and gather necessary pharmacokinetic and immunogenicity information.
CONDITIONS
Brief Title
A First-in-Human Single and Multiple Ascending Dose Study of MT-251
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants between 19 and 55 years of age (inclusive) at the time of signing informed consent.
- Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, with official documentation at least 6 months prior to the first dose.
- Male subjects must use highly effective contraception during sexual intercourse with female partners of childbearing potential; non-vasectomized males must use a condom with a chemical barrier.
- Continuous non-smoker who has not used tobacco or nicotine products for at least 3 months prior to the first dose.
- Good general health.
- Able to provide written informed consent and comply with study requirements.
You will not qualify if you...
- History or presence of any clinically significant organ system disease.
- Abnormal lab results, physical exam, or ECG outside normal range judged clinically significant by the Investigator.
- 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.
- Use of any prescription drug within 21 days or 5 half-lives before study drug; over-the-counter drugs within 7 days or 5 half-lives.
- Use of any investigational drug or device within 30 days before first dose.
- Blood donation within 60 days or plasma donation within 14 days prior to dosing.
- Sensitivity or allergy to study drugs or components contraindicating participation.
Research Team
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