Recruiting
Phase 1

MT-201

Sponsor:

Mirador Therapeutics, Inc.

Code:

NCT07219368

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

MT-201

Placebo

Study Details

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.

Conditions

Healthy Volunteer

Study ID

NCT07219368

Start date

Oct 8, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single Ascending Dose of MT-201

To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201

experimental: Multiple Ascending Dose of MT-201

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201

placebo comparator: Single Ascending Dose Placebo Arm

To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo

placebo comparator: Multiple Ascending Dose Placebo

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo

Interventions

MT-201

MT-201

Placebo

Placebo

Primary outcome measure

  • Number of Participants with non-SAEs and SAES [ Time Frame: Up to 40 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mirador Clinical Department, San Diego, California 92121

Recruiting

San Diego, California, United States, 92121

Contacts

More Information

Sponsor

Mirador Therapeutics, Inc.

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Keywords

  • MT-201
  • Phase 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mirador Therapeutics, Inc. on 2025-11-04.