What is MT-201 studying for healthy volunteers?

MT-201 is being studied to understand its safety, tolerability, how it moves through the body, and immune response in healthy adults. This helps researchers learn important information about the drug before testing in patients with specific conditions. Mirador Therapeutics, Inc. is leading this research.

Who may be eligible for this healthy volunteer clinical trial?

Adults aged 19 to 55 years who are male or females who cannot have children may be eligible. Participants must be in good general health and able to follow study instructions. People who use tobacco recently or have certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy volunteer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses vary and may not be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 19Years - 55Years

All Genders

Healthy Volunteers

ID07219368

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

Led by Mirador Therapeutics, Inc. · Updated on 2025-11-04

Participants Needed

Research Sites

5 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, tolerability, pharmacokinetics, and immune response of single and multiple doses of MT-201 in healthy adult volunteers. It is a first-in-human, phase 1 clinical trial designed to gather initial data on how MT-201 behaves in the body and its potential effects in a controlled setting. Participants will receive either single or multiple doses of MT-201 or a placebo, administered through intravenous or subcutaneous routes. The study includes randomized assignment to one of the four groups single ascending dose of MT-201, multiple ascending dose of MT-201, single ascending dose of placebo, or multiple ascending dose of placebo. Both dosing strategies will be carefully monitored to assess safety and tolerability. During the study, participants will be closely observed for any adverse events, with safety assessments conducted up to 40 weeks. Researchers will monitor vital signs, laboratory tests, and immune responses to understand MT-201s effects fully. The trial involves healthy volunteers aged between 19 and 55 years, who will be required to provide written consent and comply with study procedures throughout the duration of the trial.

CONDITIONS

Brief Title

A First-in-Human Single and Multiple Ascending Dose Study of MT-201

Who Can Participate

Age: 19Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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, with official documentation at least 6 months prior to first dose
Male participants with female partners of childbearing potential involved in heterosexual intercourse must use barrier contraception and avoid sperm donation
Good general health
Able to provide written informed consent and comply with study requirements

You will not qualify if you...

History or presence of any clinically significant organ system disease
Abnormal lab tests, physical exam, or ECG outside normal range deemed clinically significant by Investigator
History of alcohol or drug abuse within the past 24 months
Current use or history of regular tobacco or nicotine products within 3 months prior to screening
Use of any investigational drug or device within 30 days before first dose
Blood donation within 60 days or plasma donation within 14 days prior to dosing

Research Team

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