MT-251 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on testing a new treatment called MT-251 in healthy individuals. The main goal is to assess the safety and tolerability of MT-251 at various doses. The trial also examines how the body processes the drug and whether it triggers any immune reactions. Participants should be in good health, non-smokers, and free from tobacco or nicotine products for at least three months. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription drugs at least 21 days before the study, and any over-the-counter drugs at least 7 days before the study.
Is there any evidence suggesting that MT-251 is likely to be safe for humans?
Research shows that MT-251 is undergoing its first human trials to assess safety and tolerability. As a result, detailed information from previous human studies is not yet available.
MT-251 is in a Phase 1 trial, the initial stage of human testing. These trials typically involve a small group of healthy volunteers and focus on evaluating the treatment's safety. Researchers monitor for side effects and how the body processes the drug.
No serious adverse reactions have been reported so far, which is expected at this early stage. Phase 1 trials are crucial for understanding a treatment's basic safety before further testing.12345Why do researchers think this study treatment might be promising?
Researchers are excited about MT-251 because it is designed to be administered both intravenously and subcutaneously, offering flexible delivery options. Unlike traditional treatment methods that might rely on oral administration, this approach can provide more direct and potentially faster absorption into the bloodstream. Additionally, MT-251 is being tested for both single and multiple ascending doses, which could provide insights into how varying dosages affect safety and tolerability, potentially broadening its applicability.
What evidence suggests that MT-251 could be effective?
Researchers are studying MT-251, a new treatment, to assess its safety and how the body processes it. Initial research focuses on safety and tolerance. This study marks the first human testing of MT-251, so no solid evidence exists yet on its effectiveness for any condition. Participants will be divided into two groups: one will receive a single ascending dose, while the other will receive multiple ascending doses. Researchers are still determining how the drug functions in the body and its safety for further testing. If MT-251 proves safe and well-tolerated, future studies might explore its potential benefits for specific diseases.12367
Are You a Good Fit for This Trial?
This trial is for healthy men and women aged 19 to 55. Men must use reliable birth control, and women must not be able to have children (postmenopausal or surgically sterile). Participants should be non-smokers for at least 3 months and in good general health.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose
Participants receive a single intravenous/subcutaneous dose of MT-251 to assess safety and tolerability
Multiple Ascending Dose
Participants receive multiple intravenous/subcutaneous doses of MT-251 to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MT-251
Trial Overview
The study tests different single and multiple doses of a new drug called MT-251 compared to a placebo. It is randomized, double-blind, and aims to assess safety, tolerability, how the body processes the drug, and immune response in healthy volunteers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-251.
To assess the safety and tolerability of single intravenous/subcutaneous dose of MT-251.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mirador Therapeutics, Inc.
Lead Sponsor
Citations
A First-in-Human Single and Multiple Ascending Dose ...
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-251 in healthy ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-first-in-human-single-and-multiple-ascending-dose-study-of-mt251A First-in-Human Single and Multiple Ascending Dose Study ...
This is a first-in-human study of MT-251, a biologic therapeutic. The purpose of the study is to evaluate the safety, tolerability, ...
MT-251 for Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and ...
A Phase 1, Randomized, Open‐Label, Safety, Tolerability, and ...
This healthy subject study was designed to evaluate the tolerability, safety, and PK profile of STS101, a novel drug‐device combination product containing a ...
First-in-Human Clinical Trial to Assess the Safety, Tolerability ...
This first-in-human study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of NTM-1633.
A First-in-Human Single and Multiple Ascending Dose ...
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-251. Primary Outcome Measure. Number of Subjects with non-SAEs and ...
A First-in-Human Single and Multiple Ascending Dose ...
A First-in-Human Single and Multiple Ascending Dose Study of MT-251. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, ...
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