Actively Recruiting
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
72
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
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-201's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks
Participants receive single or multiple ascending doses of MT-201 or placebo by intravenous or subcutaneous administration to assess safety and tolerability.
Multiple visits for dosing and safety assessments depending on dosing schedule
Trial Site Locations
Total: 1 location
1
Mirador Clinical Department, San Diego, California 92121
San Diego, California, United States, 92121
Actively Recruiting
Research Team
T
Toll-Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here