Mosliciguat for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called mosliciguat to understand how the body absorbs, breaks down, and eliminates it. Researchers aim to ensure its safety for healthy adults. The treatment is administered in two ways: via inhaler and orally or by IV (a drip into the vein). Healthy men without lung issues such as asthma or COPD (a common lung disease) are suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mosliciguat, when inhaled, is generally well-tolerated by healthy adults. Three different studies found no serious side effects with once-daily inhaled doses, indicating that the body can handle the drug well without causing major health problems.
For mosliciguat taken orally or through an IV, specific safety information is not yet available. However, these forms are currently being tested in a Phase 1 study, which primarily assesses safety in humans. Phase 1 studies are early tests, so while more information is needed, testing in humans suggests it is expected to be safe under controlled conditions.12345Why are researchers excited about this trial's treatments?
Mosliciguat is unique because it is administered as a dry powder inhaler, offering a potentially more convenient and faster-acting delivery method compared to traditional pills or injections. This inhalation approach might provide quicker absorption, which could lead to faster therapeutic effects. Additionally, mosliciguat's novel mechanism of action involves targeting specific pathways in the body that current treatments might not address, potentially leading to better outcomes. Researchers are excited about this treatment because it could offer a new and effective option for patients, enhancing both convenience and efficacy.
What evidence suggests that mosliciguat could be effective?
This trial will compare two methods of administering mosliciguat to healthy subjects. Research suggests that mosliciguat might be particularly effective when inhaled. Studies in healthy men have shown that it remains in the body longer when inhaled than when taken orally or through an IV. This could improve outcomes for certain health issues. In other research, mosliciguat demonstrated positive effects in treating pulmonary hypertension, which is high blood pressure in the lungs. These early findings indicate potential benefits, but further research is needed to confirm its efficacy for specific conditions.15678
Who Is on the Research Team?
Ubaldo Martin
Principal Investigator
Pulmovant, Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adult males who are in good health as determined by medical exams, ECG, and lab tests. They must be willing to consent to the study. Men with recent respiratory infections, chronic lung diseases like COPD or asthma within the last 5 years, or conditions that could risk safety or study goals can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mosliciguat via dry powder inhaler and [14C]-mosliciguat orally and via IV to assess bioavailability, absorption, metabolism, and excretion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Mosliciguat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulmovant, Inc.
Lead Sponsor