MT-201 for Healthy Volunteers

Overseen By Toll-Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirador Therapeutics, Inc.

Disqualifiers: Organ disease, Abnormal labs, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MT-201 to determine its safety and how the body processes it. Participants will receive either a single or multiple doses of MT-201 or a placebo (a substance with no therapeutic effect) to compare reactions. The trial seeks healthy volunteers who generally feel well and have no significant health issues. Those who haven't used tobacco or drugs recently and are willing to follow study rules might be a good fit. As a Phase 1 trial, this research focuses on understanding how MT-201 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy volunteers, it's likely that participants should not be on any regular medications.

Is there any evidence suggesting that MT-201 is likely to be safe for humans?

Research shows that MT-201 is being tested in humans for the first time, so no safety results from previous human trials exist. This early phase study primarily focuses on assessing the safety and tolerability of MT-201. Researchers closely monitor such studies to ensure participant safety.

In this trial, participants will receive either one or multiple doses of MT-201. Although detailed safety results are not yet available, these early trials typically begin with low doses to identify any side effects and adjust as needed. If MT-201 had already been approved for another condition, it might be considered safer, but that is not the case here. Researchers monitor participants for any side effects, and the trial prioritizes safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MT-201 because it introduces a novel approach to treatment with its unique mechanism of action. Unlike standard treatments that might focus on symptom management, MT-201 is designed to target the underlying biological pathways more directly. This could potentially lead to improved safety and tolerability, as it is administered in both single and multiple ascending doses to understand its effects thoroughly. By potentially offering a more precise intervention, MT-201 might pave the way for more effective and tailored treatment strategies for future applications.

What evidence suggests that MT-201 could be effective?

MT-201 is a new treatment undergoing its first test in this trial. Its effectiveness remains unknown as it is still in the early testing stages. Participants will receive either single or multiple ascending doses of MT-201, or a placebo, to assess safety and tolerability. The primary focus is on understanding how the body processes the drug and its safety profile. Researchers are examining the drug's movement through the body and any potential immune reactions. With no existing data on its effectiveness, the main goal is to ensure it can be safely administered to people. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting conditions.

Inclusion Criteria

Good general health

Able to provide written informed consent and understand and comply with the requirements of the study

I am between 19 and 55 years old and cannot become pregnant or am a male.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple doses of MT-201 or placebo to assess safety, tolerability, pharmacokinetics, and immunogenicity

Up to 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MT-201

Trial Overview The trial is examining MT-201, which is being given to some participants, while others receive a placebo. The study aims to understand how safe MT-201 is and how it affects the body (pharmacokinetics) when taken once or multiple times.

How Is the Trial Designed?

Group I: Single Ascending Dose of MT-201 Experimental Treatment 1 Intervention

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

Group II: Multiple Ascending Dose of MT-201 Experimental Treatment 1 Intervention

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

Group III: Single Ascending Dose Placebo Arm Placebo Group 1 Intervention

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

Group IV: Multiple Ascending Dose Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Mirador Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219368

A First-in-Human Single and Multiple Ascending Dose ... First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in ...

2. trial.medpath.com trial.medpath.com/clinical-trial/92ce8c2ba0534863/nct07219368-phase1-mt201-safety-healthy-participants

A First-in-Human Single and Multiple Ascending Dose Study ... First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy ...

3. facebook.com facebook.com/groups/2688029951255361/posts/25270106135954421/

New phase 1 in healthy volunteers for an oral drug ... The Phase Ib MAD study is a randomized, double -blind, placebo-controlled study, conducted in the U.S., to evaluate safety and tolerability, ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04464681

Multiple Dose Escalation Study of M201-A in Healthy ... This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8742633/

Evaluation of the safety, tolerability, and pharmacokinetics ... The objectives of this phase I study are to assess the safety, tolerability, and pharmacokinetics (PKs) of RO7049389 in healthy Chinese volunteers (HVs) and ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-b5459

MT-201 for Healthy Volunteers Participants receive single and multiple doses of MT-201 or placebo to assess safety, tolerability, pharmacokinetics, and immunogenicity. Up to 36 weeks.

7. meddatax.com meddatax.com/clinical-trials/NCT07219368

A First-in-Human Single and Multiple Ascending Dose Study of MT ... First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy ...

8. ichgcp.net ichgcp.net/amp/clinical-trials-registry/556281-a-first-in-human-single-and-multiple-ascending-dose-study-of-mt-201

MT-201 Clinical Research Study for Healthy Volunteers - Clinical ... This clinical research study focuses on evaluating the safety and tolerability of an investigational medication called MT-201 in healthy adult participants.