NCT07219368 A First-in-Human Single and Multiple Ascending Dose Study of MT-201
| NCT ID | NCT07219368 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mirador Therapeutics, Inc. |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2026-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-10-08 with a primary completion date of 2026-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07219368 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219368 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07219368 currently recruiting?
Yes, NCT07219368 is actively recruiting participants. Contact the research team at clinicaltrials@miradortx.com for enrollment information.
Where is the NCT07219368 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT07219368 clinical trial?
NCT07219368 is sponsored by Mirador Therapeutics, Inc.. The trial plans to enroll 72 participants.