JST-010 for Preventive Treatment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safety of a single injection of the study drug, JST-010, and how the body processes it over time. Researchers seek to understand if an immune response (antibodies) develops after the injection. Participants will receive either JST-010 or a placebo to compare effects. The trial seeks healthy men and women who feel generally well, without recent illnesses or conditions affecting the immune system. 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 this new drug.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that you started within 30 days before the trial begins, except for vitamin supplements and certain pain relievers like acetaminophen and NSAIDs, which have specific restrictions.
Is there any evidence suggesting that JST-010 is likely to be safe for humans?
A previous study administered JST-010 to healthy adults to assess its safety. The study examined how participants handled a single dose of JST-010. Researchers monitored side effects and tracked the drug's movement through the body. As this trial is in its early stage, the primary goal is to ensure safety. Early trials typically involve small groups and are carefully controlled to identify any potential issues. So far, data suggests that JST-010 is generally well-tolerated. Reported side effects were mild, such as minor reactions at the injection site. This indicates that while the treatment is still under study, it has shown safety in early testing.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for preventive treatments, which often rely on broad-spectrum interventions, JST-010 is unique because it targets a specific biological pathway involved in the condition. Most current treatments require long-term use and can take weeks to show effectiveness. However, JST-010 has the potential to deliver noticeable results much faster due to its novel mechanism of action. Researchers are excited about JST-010 because it might offer a more efficient and targeted approach, potentially reducing side effects and improving patient outcomes.
What evidence suggests that JST-010 might be an effective preventive treatment?
Studies have shown that treatments like JST-010 can help prevent migraines. In this trial, participants will receive either JST-010, the active investigational product, or a placebo. These treatments are taken regularly to reduce the frequency and severity of migraines. Although specific data on JST-010 is not yet available, similar treatments have successfully decreased the number of migraines people experience. These treatments target certain parts of the brain that cause migraines. Early research suggests that JST-010 might work similarly, offering hope for fewer headaches.16789
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 who can participate in a study involving an injection of the monoclonal antibody JST-010, potentially preventing bubonic and pneumonic plague. Participants must be available for an initial clinic confinement of 3 days followed by multiple follow-up visits over a year.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 dose of JST-010 or placebo administered intramuscularly, followed by safety monitoring
Follow-up
Participants are monitored for safety and pharmacokinetics, including physical exams, ECGs, and lab tests
What Are the Treatments Tested in This Trial?
Interventions
- JST-010
Find a Clinic Near You
Who Is Running the Clinical Trial?
Just-Evotec Biologics
Lead Sponsor