A First-in-Human Single and Multiple Ascending Dose Study of MT-201
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
| Condition(s) | Healthy Volunteer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 sign |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Mirador Therapeutics, Inc. |
| Locations | San Diego, California, United States |
| Start date | 2025-10-08 |
| NCT ID | NCT07219368 |
| Official listing | https://clinicaltrials.gov/study/NCT07219368 |