Sotatercept Formulations in Healthy Individuals
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different forms of the medication sotatercept behave in the bodies of healthy individuals. Researchers aim to determine if differences arise when administering the medication through various methods, such as a syringe or an autoinjector, and at different doses. Individuals who are generally healthy, weigh between 75 and 100 kg, and meet specific reproductive history criteria may qualify. 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 medication.
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 or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sotatercept is usually well-tolerated when administered as an injection under the skin. In less than 1% of cases, no specific side effects led to treatment discontinuation. However, some serious side effects, such as bleeding and low platelet counts, have been observed, particularly in patients also receiving prostacyclin therapy. Sotatercept may also raise hemoglobin levels, potentially causing blood clotting issues.
Long-term safety data from various studies indicate that sotatercept maintains a consistent safety record over time. Although the treatment remains under study, these findings suggest that sotatercept is generally safe, despite some risks. Discussing potential side effects with a healthcare provider is important before joining a trial.12345Why are researchers excited about this trial's treatments?
Sotatercept is unique because it targets a specific pathway involved in bone and blood vessel health, which is different from many current treatments for related conditions that often focus on symptom management rather than underlying causes. Researchers are excited about sotatercept's potential because it can be administered via both syringe and autoinjector, offering flexibility and possibly improving patient compliance. Additionally, the trial is exploring both high and low doses, which might help optimize the balance between efficacy and side effects, potentially leading to a more personalized treatment approach.
What evidence suggests that this trial's treatments could be effective?
This trial will compare different formulations of sotatercept in healthy individuals. Studies have shown that sotatercept can help treat pulmonary arterial hypertension (PAH), a condition where high blood pressure affects the arteries in the lungs. Research suggests that sotatercept lowers the risk of serious health issues in people with advanced PAH by blocking certain signals in the body that contribute to the disease. Patients have experienced improvements when sotatercept is added to their treatment plan. While more information is needed about long-term effects, early results are promising for those with PAH.678910
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy females who weigh between 75 and 100 kg. They must be either premenarchal, premenopausal with a hysterectomy/salpingectomy, have a medical cause of permanent infertility, or be postmenopausal.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 sotatercept, either high or low, administered via syringe or autoinjector
Follow-up
Participants are monitored for pharmacokinetics and safety, with blood samples collected at designated timepoints
What Are the Treatments Tested in This Trial?
Interventions
- Sotatercept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University