New Formulations of TEV-56286 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how the body absorbs different formulations of a drug called TEV-56286 in healthy adults. Researchers also seek to assess the safety and tolerability of these formulations. Participants will try both new and existing versions of the drug. The trial seeks healthy individuals with a body mass index (BMI) between 18.5 and 32 who have not recently participated in another trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug formulation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please contact the investigator for more details.
Is there any evidence suggesting that TEV-56286 is likely to be safe for humans?
Research has shown that TEV-56286, also known as emrusolmin, is under study for its safety and effectiveness. The FDA has granted it Fast Track designation for Multiple System Atrophy, a rare brain disorder, indicating promise in earlier tests.
As this trial is in its early stages, detailed information on tolerance is limited. In this Phase 1 trial, the primary goal is to assess safety in healthy volunteers. Researchers closely monitor responses to the drug, including any side effects.
In summary, while the FDA's Fast Track designation is encouraging, more information will emerge as the trial progresses. Participants receive close monitoring to ensure safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about TEV-56286 because it offers a new formulation that might improve how the body absorbs the medication. Unlike current treatments for similar conditions that may have slower or less predictable absorption, TEV-56286 is designed to enhance bioavailability, potentially leading to quicker and more consistent effects. This could mean faster relief for patients and more reliable outcomes, setting it apart from existing options.
What evidence suggests that TEV-56286 might be an effective treatment?
Research has shown that TEV-56286 is being tested as a treatment for multiple system atrophy (MSA), a rare brain disorder. In one study, 71.4% of MSA patients showed improvement after receiving a high dose of intravenous amantadine, a component of the treatment, for five days. This suggests that TEV-56286 might help improve MSA symptoms. While the current trial focuses on evaluating how well TEV-56286 is absorbed in different formulations, earlier studies suggest it could be beneficial.678910
Who Is on the Research Team?
Teva Medical Expert, MD
Principal Investigator
Teva Branded Pharmaceutical Products R&D LLC
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI of 18.5 to 32 who agree to prevent pregnancy during the study. Men must use contraception unless they are sterile. People can't join if they have a history of heart issues, are in another trial, have substance abuse within the last year, donated blood recently or plan surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single-dose administration of TEV-56286 test and reference formulations in a randomized crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TEV-56286
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Branded Pharmaceutical Products R&D LLC
Lead Sponsor