Safety, Tolerability, and Pharmacokinetics of a Novel Nitroimidazooxazole Antitubercular Agent in Healthy Adults: A Phase I Trial.

ABSTRACT: This study evaluated the safety, tolerability, and pharmacokinetics of JBD0131, a novel nitroimidazooxazole antitubercular agent, in healthy adults. We previously reported JBD0131, a novel nitroimidazooxazole antitubercular agent, which overcomes drug resistance and bioavailability limitations of existing anti-tuberculosis therapies. The clinical trial was structured into three parts: an initial single ascending dose (SAD) phase under fasting conditions, a food-effect assessment, and a final multiple ascending dose (MAD) phase conducted after meals.  Among 95 enrolled participants, JBD0131 demonstrated favorable safety and tolerability across all regimens. No serious adverse events (AEs) or treatment discontinuations occurred. Treatment-emergent AE incidence was comparable to placebo witho

SUBMITTER: Miao J 

PROVIDER: S-EPMC12678841 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature