TVB-3567 for Acne
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral treatment called TVB-3567 to determine its safety and tolerability, particularly for individuals with moderate to severe acne. The study consists of four parts: two involve healthy volunteers, and two examine how the body processes TVB-3567, including the impact of food. Parts C and D will assess its effects with repeated doses, with Part D specifically targeting those with acne. The trial seeks healthy participants and individuals with moderate to severe acne who have not recently used certain acne medications. 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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements before joining the trial. Additionally, you must avoid certain acne treatments and drugs that affect specific enzymes starting 28 days before the trial.
Is there any evidence suggesting that TVB-3567 is likely to be safe for humans?
Research shows that TVB-3567 is a new drug being tested for acne. This Phase 1 trial marks the first time TVB-3567 is being used in humans, so detailed safety information is not yet available. TVB-3567 is an FASN inhibitor. Another drug, denifanstat, which functions similarly, has been tested for acne and was generally well tolerated in those studies. This suggests that TVB-3567 might also be well tolerated, but confirmation awaits further data from the ongoing trials.12345
Why do researchers think this study treatment might be promising for acne?
Unlike the standard acne treatments like benzoyl peroxide, salicylic acid, or antibiotics, TVB-3567 introduces a novel approach. Most treatments work by reducing bacteria or inflammation on the skin. However, TVB-3567 works differently, targeting the root causes of acne at a molecular level, potentially offering a new way to clear skin more effectively. Researchers are excited because this could mean fewer side effects and improved outcomes for those struggling with persistent acne.
What evidence suggests that TVB-3567 might be an effective treatment for acne?
Research has shown that TVB-3567 might help treat acne. Early results from its partner, Ascletis, were promising for treating Acne Vulgaris, a common type of acne. Patients experienced a noticeable decrease in both red, swollen pimples and smaller, non-swollen spots. Another study found that it positively affected skin oil, which is important because excess oil can block pores and cause acne. Although researchers are still studying this treatment, these early findings suggest TVB-3567 could effectively manage acne. Participants in this trial will join different study parts, including those focusing on healthy individuals and those specifically with acne.23567
Are You a Good Fit for This Trial?
This trial is for healthy individuals, some with moderate to severe acne. Participants will be given TVB-3567 or a placebo orally. The study excludes certain people based on undisclosed criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Randomized, double-blind, placebo-controlled investigation of single ascending doses to assess safety, tolerability, PK, and PD biomarkers
Food Effect
Open-label, 2-way crossover investigation to assess the effect of food on a single dose
Multiple Ascending Dose (MAD)
Randomized, double-blind, placebo-controlled investigations of multiple ascending doses to assess safety, tolerability, PK, and PD/biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TVB-3567
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sagimet Biosciences Inc.
Lead Sponsor