MAR002 for Safety Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new treatment called MAR002, administered by injection, in healthy men. Researchers are exploring how the body processes different doses of this treatment. As a Phase 1 trial, the focus is on ensuring the treatment's safety before proceeding to more extensive testing. Men who consider themselves healthy and meet specific criteria, such as having no history of substance abuse or serious illness, might be suitable candidates. Participants must weigh between 55 and 95 kg and have a BMI between 18 and 30. In this Phase 1 trial, participants will be among the first to receive this new treatment, contributing to understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MAR002 underwent early studies to assess its safety. These preclinical studies suggested that MAR002 was generally safe in animals, with no major safety issues identified.
Currently, this treatment is in its first phase of human testing. This marks the first time MAR002 is being administered to people to evaluate its safety. As it is still early, there may not be extensive information from human tests yet. However, reaching this stage indicates that earlier studies provided researchers with enough confidence to proceed with human trials.
The primary goal now is to determine if MAR002 causes any side effects when administered to healthy men. This step helps ensure its safety for a broader population in the future. Safety information will become more detailed as the trial progresses.12345Why are researchers excited about this trial's treatment?
Researchers are excited about MAR002 because it offers a new approach to treatment with its subcutaneous injection method. Unlike traditional oral medications or intravenous therapies, this method can provide a more direct and potentially faster delivery of the active ingredient. This could mean a quicker onset of action and possibly improved patient compliance due to the ease of administration. Additionally, with multiple dosing options being explored, MAR002 could offer customizable treatment plans tailored to individual patient needs, which is a significant step forward in personalized medicine.
What evidence suggests that this trial's treatments could be effective?
Research has shown that MAR002 could be a promising treatment for acromegaly, a condition characterized by excessive growth hormone production. MAR002 is a specially designed antibody that blocks the growth hormone receptor, potentially reducing its effects. Early lab research, conducted before human testing, indicates that MAR002 effectively targets the growth hormone pathway. Although detailed human data remains limited, similar treatments have proven effective for other conditions. These early findings suggest that MAR002 might help manage growth hormone levels in individuals with acromegaly.15678
Are You a Good Fit for This Trial?
This trial is for healthy men aged 18 to 40, weighing between 55 to 95 kg with a BMI of 18 to 30 kg/m2. Participants must be willing to consent in writing and not have recently donated blood, used substances or nicotine, or been part of another drug study. They should also have no history of pituitary disorders, cancer, acute illnesses, hypersensitivity to monoclonal antibodies or the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of MAR002
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MAR002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marea Therapeutics
Lead Sponsor