Healthy VolunteerPhase 1NCT07219368
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
A Phase 1 study testing MT-201 in people with Healthy Volunteer, run by Mirador Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MT-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participant or female participant of nonchildbearing potential 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, and have official documentation, at least 6 months prior to the first dose.
- 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.
- Good general health.
- Able to provide written informed consent and understand and comply with the requirements of the study.
Who cannot join
- History or presence of any clinically significant organ system disease.
- Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
- 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.
- Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
- Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mirador Clinical Department, San Diego, California 92121
San Diego, California, 92121
Mirador Clinical Department, 844-206-4980, ClinicalTrials@Miradortx.com
Toll-Free Number
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants
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
- Being tested
- MT-201, Placebo
- Keywords
- MT-201, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-201Drug
MT-201
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose of MT-201 | Experimental | To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201 Receives: Drug: MT-201 |
| Multiple Ascending Dose of MT-201 | Experimental | To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201 Receives: Drug: MT-201 |
| Single Ascending Dose Placebo Arm | Placebo comparator | To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo Receives: Drug: Placebo |
| Multiple Ascending Dose Placebo | Placebo comparator | To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with non-SAEs and SAES
Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start8 Oct 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirador Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219368
- Sponsor's protocol ID
- MT-201-101
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07219368
- Acronym / sponsor ID
- MT-201-101
- Conditions
- Healthy Volunteer
- Keywords
- MT-201, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mirador Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose of MT-201 | Experimental | Drug: MT-201To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201 |
| Multiple Ascending Dose of MT-201 | Experimental | Drug: MT-201To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201 |
| Single Ascending Dose Placebo Arm | Placebo comparator | Drug: PlaceboTo assess the safety and tolerability of single intravenous/subcutaneous doses of placebo |
| Multiple Ascending Dose Placebo | Placebo comparator | Drug: PlaceboTo assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participant or female participant of nonchildbearing potential 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, and have official documentation, at least 6 months prior to the first dose.
- 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.
- Good general health.
- Able to provide written informed consent and understand and comply with the requirements of the study.
Key exclusion criteria (6 listed)
- History or presence of any clinically significant organ system disease.
- Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
- 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.
- Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-201MT-201 | Drug | Multiple Ascending Dose of MT-201, Single Ascending Dose of MT-201 |
| PlaceboPlacebo | Drug | Multiple Ascending Dose Placebo, Single Ascending Dose Placebo Arm |
Primary outcome
Number of Participants with non-SAEs and SAES
Time frame: Up to 40 weeks
Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-201 in people with Healthy Volunteer, run by Mirador Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll-Free Number (844-206-4980, clinicaltrials@miradortx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with non-SAEs and SAES (time frame: Up to 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.