MT-701 for Safety Evaluation in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and metabolism of a new treatment called MT-701, an experimental therapy. Researchers will administer either a single dose or multiple doses to healthy participants to assess tolerance and any immune response. The trial seeks individuals in good general health who haven't used tobacco products in the last three months and aren't taking regular medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription drugs 21 days before the study and any over-the-counter drugs 7 days before the study.
Is there any evidence suggesting that MT-701 is likely to be safe for humans?
Research shows that MT-701 is undergoing its first human trials to assess safety. As this marks the initial use of MT-701 in people, direct safety information is not yet available. The trial will evaluate how well participants tolerate the treatment and identify any side effects. In this early stage, the study primarily focuses on determining the treatment's safety and the body's reaction. Since there is no prior evidence of its safety in humans, participants will contribute to establishing this information.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about MT-701 because it offers a new approach to assessing safety and tolerability in healthy individuals. Unlike other treatments, MT-701 is being evaluated in both single and multiple ascending doses, administered either intravenously or subcutaneously. This dual approach allows for a more comprehensive understanding of the drug's effects, potentially leading to safer and more effective dosing strategies in the future.
What evidence suggests that MT-701 could be effective?
Research shows that MT-701 is a new treatment under investigation for its potential benefits. As this is the first human trial, limited information exists on its effectiveness. The trial consists of two parts: one where participants receive a single ascending dose and another with multiple ascending doses. The primary goal is to determine its safety and tolerability in healthy individuals. Scientists are still studying MT-701's mechanism, but it is designed to interact with the immune system, which could be promising for future treatments. Early results will clarify its safety and how the body processes it, which is crucial before testing its efficacy in treating specific conditions.12346
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 19-55 who can consent to study requirements. Women must be unable to bear children, either postmenopausal or surgically sterile with documentation. Men should use effective contraception during the study.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-701 to assess safety and tolerability
Multiple Ascending Dose
Participants receive multiple intravenous/subcutaneous doses of MT-701 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-701
Trial Overview
The trial tests MT-701's safety and how it affects the body (pharmacokinetics) in single and multiple doses on healthy people. It also checks if the body creates any immune response against MT-701.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-701.
To assess the safety and tolerability of single intravenous/subcutaneous dose of MT-701.
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-701 in healthy ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-first-in-human-single-and-multiple-ascending-dose-study-of-mt701A First-in-Human Single and Multiple Ascending Dose Study ...
This is a first-in-human study of MT-701, a biologic therapy. The purpose of the study is to evaluate the safety, tolerability, ...
A Phase 1, Randomized, Double-Blind, Placebo-Controlled ...
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-701 ...
4.
mountsinai.org
mountsinai.org/clinical-trials/study-to-evaluate-safety-efficacy-of-booster-dose-of-bnt162b2-against-covid-19-in-participants-16-years-of-ageTo Evaluate the Safety, Tolerability, Efficacy and ...
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for ...
5.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT04501744/a-study-of-m701-epcam-and-cd3-in-malignant-ascitesA Study of M701 (EpCAM and CD3) in Malignant Ascites
This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients ...
6.
mentalhealth.networkofcare.org
mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT05030831?keyword=%22Pseudoxanthoma%20Elasticum%22Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in ...
This study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of INZ-701. The goal of ...
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