Pharmacokinetics, safety, and tolerability of nacubactam (OP0595) after intravenous infusion: a randomized, double-blind, placebo-controlled phase I clinical trial in healthy Chinese male subjects.

ABSTRACT: The rise of carbapenem-resistant Enterobacteriaceae (CRE) has posed a major clinical challenge, with limited treatment options. Nacubactam, a novel β-lactamase inhibitor, combined with cefepime or aztreonam, effectively supports CRE infection treatment. A randomized, double-blind, placebo-controlled clinical trial was conducted for the first time in healthy male Chinese subjects, including both single and multiple doses 60 ± 5-min intravenous infusion. Twenty participants were randomly assigned to nacubactam or placebo in two dosage groups (1 g and 2 g, 10 subjects each) to evaluate pharmacokinetics, safety, and tolerability. Nacubactam demonstrated good safety and tolerability in healthy male Chinese subjects after single and multiple doses intravenous infusion with no adverse events lead

SUBMITTER: Qiu H 

PROVIDER: S-EPMC12775105 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature