Pharmacokinetics, tolerability, and safety of TBI-223, a novel oxazolidinone, in healthy participants.

ABSTRACT: TBI-223 is an oxazolidinone antibiotic under clinical development for the treatment of tuberculosis. Preclinical data indicate potent antituberculosis activity and a potentially improved safety profile over linezolid. In a single-ascending dose study and a multiple-ascending dose study in 114 healthy adults, TBI-223 was generally safe and well tolerated at single doses up to 2,600 mg and multiple doses up to 2,400 mg daily over 14 days. No deaths, serious or severe adverse events, or discontinuations resulting from adverse effects (other than COVID-19) occurred. Except for two instances of orthostatic tachycardia in the single-ascending dose (SAD) study that resolved, no clinically significant electrocardiogram changes were noted. Concentration-QTc modeling found significant relationships

SUBMITTER: Lombardi A 

PROVIDER: S-EPMC11963608 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature