Phase 1 Clinical Trial Evaluating Safety, Tolerability, and Effects of Oral TVB-3567 in Healthy Adults With or Without Moderate to Severe Acne

What this Trial Is About

Researchers are evaluating TVB-3567 in healthy adults with or without moderate to severe acne through a 4-part Phase 1 study. The study aims to assess the safety, tolerability, pharmacokinetics PK, and pharmacodynamic PD biomarkers of this oral drug. Parts A and B focus on single doses, including the effects of food on the drug, while Parts C and D study multiple doses in healthy participants and those with acne, respectively. Participants will receive TVB-3567 or a placebo as orally administered capsules. Part A involves randomized, double-blind, placebo-controlled single ascending doses to assess safety and drug behavior. Part B is an open-label crossover study examining the impact of food on a single dose. Parts C and D are randomized, double-blind, placebo-controlled multiple ascending dose studies in healthy and acne-affected participants, respectively. During the study, participants will undergo safety monitoring including assessment of adverse events and serious adverse events at various time points after dosing. Pharmacokinetic measures such as plasma drug concentration over time will be evaluated, especially in Part B. The study includes follow-ups up to 13 to 15 days after the last dose in Parts C and D. Overall participation will last from a few days to weeks depending on the study part, with detailed monitoring of drug effects and safety.

Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne