Bacterial top IV x Bacterial DNA gyrase x RNAP

This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.

评价注射用TNP-2092在中国健康受试者中单剂、多剂连续静脉输注给药的安全性和耐受性； 评价注射用TNP-2092在中国健康受试者中单剂、多剂连续静脉输注给药的药代动力学特征。

This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).