TBD09 for Safety Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and metabolism of a new treatment called TBD09, an experimental therapy. Healthy participants will receive either the treatment or a placebo (a non-active substance that looks the same) daily for 84 days. The study seeks to ensure that TBD09 is safe and well-tolerated. Participants must be healthy, non-smokers, and free from major diseases or recent drug use. 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 treatment.
Do I need to stop taking my current medications to join the trial?
Yes, you will need to stop taking any prescription or over-the-counter medications, vitamins, dietary supplements, or herbal products at least 14 days before the trial starts.
Is there any evidence suggesting that TBD09 is likely to be safe for humans?
Research has shown that TBD09, also known as MK-7762, is just beginning human testing. As a result, limited information exists about its safety. The current study marks the first step in assessing how well people can tolerate this treatment. As a Phase 1 trial, the primary goal is to determine if TBD09 is safe for healthy adults over a specified period.
In earlier studies, TBD09 was administered in both single and multiple doses to healthy adults to evaluate side effects and how the body processes it. No serious side effects have been reported so far, but since this is early research, focusing on safety remains crucial as more data emerges. Prospective participants should understand that this trial aims to gather new safety information.12345Why do researchers think this study treatment might be promising?
TBD09 is unique because it offers a novel approach in treating conditions that typically rely on standard treatments like medications targeting specific symptoms or pathways. Unlike existing options, TBD09 may have a new mechanism of action that could potentially target the root cause more directly. Researchers are excited about TBD09 as it promises a different pathway for treatment, possibly leading to more effective and faster results with fewer side effects. This could represent a significant advancement over current therapies and improve outcomes for patients.
What evidence suggests that TBD09 could be an effective treatment?
Research has shown that TBD09, also known as MK-7762, is under study for its potential to treat tuberculosis. TBD09 targets the bacteria causing the disease, possibly inhibiting their growth. Early results suggest it might help control these bacteria. In this trial, participants will receive either TBD09 or a placebo to evaluate safety. However, the trial focuses on safety rather than directly treating tuberculosis, so there is no direct evidence yet of its effectiveness in patients. This research is an important step in understanding how TBD09 works in the body and its possible benefits.12367
Are You a Good Fit for This Trial?
This trial is for healthy adults who have a BMI between 18-32, weigh at least 50 kg, and have normal blood pressure and heart rate. They must be non-smokers for the past 90 days, able to follow trial procedures, and stay in the facility during inpatient periods.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either TBD09 or placebo once daily for 84 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TBD09
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gates Medical Research Institute
Lead Sponsor