Selatogrel for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how a new drug, selatogrel, behaves in the body and its effects after a single dose. It focuses on healthy Japanese and Caucasian participants to understand how their bodies absorb and respond to the medication. Individuals who are generally healthy and have no history of asthma or certain blood disorders might be suitable candidates. The study aims to provide researchers with insights into the drug's safety and potential use in future treatments. Participants will spend a few days in a clinic and undergo follow-up checks. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking any prescribed or over-the-counter medications, including herbal medicines, at least 2 weeks before the study drug is given.
Is there any evidence suggesting that selatogrel is likely to be safe for humans?
Research has shown that selatogrel, when administered as a single dose, is generally safe and well-tolerated. Studies with healthy individuals indicate it can be used without serious side effects. Even at the highest dose tested (32 mg), no major problems occurred. Some possible side effects include an increased risk of bleeding due to selatogrel's effect on blood clotting. However, no serious adverse effects have been reported. This suggests that selatogrel is safe for use in clinical settings, particularly when given as a single dose to healthy individuals.12345
Why are researchers excited about this trial?
Selatogrel is unique because it offers a new way to prevent blood clots. Unlike other treatments that are usually taken orally and can take some time to kick in, Selatogrel is administered as a subcutaneous injection, which means it can work quickly and directly. This fast-acting approach is especially promising for acute situations where rapid intervention is critical. Researchers are excited about Selatogrel because it may offer a quicker, potentially more efficient alternative to standard oral blood thinners.
What evidence suggests that selatogrel is effective?
This trial will compare Selatogrel with a placebo. Studies have shown that Selatogrel quickly stops blood cells called platelets from sticking together. This action is important because it can help prevent heart attacks by improving blood flow. Research also shows that Selatogrel is safe and well-tolerated in healthy people, even at high doses. Its rapid effect and safety make it a promising option for preventing heart problems.12346
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Viatris Innovation GmbH
Are You a Good Fit for This Trial?
This trial is for healthy Japanese and Caucasian individuals with a BMI of 18.0 to 28.0, normal ECG, blood tests within the normal range, and no drug or alcohol abuse. Participants must be able to follow the study's procedures and use effective contraception if applicable.Inclusion 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 selatogrel or placebo and are monitored for pharmacokinetics and pharmacodynamics
End-of-trial examination
An examination conducted at least 36 hours after study drug administration to assess the primary outcome measures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Selatogrel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viatris Innovation GmbH
Lead Sponsor