[Translation] A single-center, randomized, blinded, placebo-controlled, phase I clinical tolerability trial of single and multiple-dose ceftazidime sodium for injection in healthy humans;
观察健康人体单次和多次接受注射用头孢他美钠的安全性和耐受性,评估注射用头孢他美钠在健康人体单次和多次给药的安全剂量范围,确定健康人体单次和多次用药的最大耐受量,为制定I期药代动力学研究及II期临床试验给药方案提供依据。
[Translation] To observe the safety and tolerability of single and multiple administrations of ceftazidime sodium for injection in healthy subjects, evaluate the safe dose range of single and multiple administrations of ceftazidime sodium for injection in healthy subjects, and determine the single dose of ceftazidime sodium for injection in healthy subjects and the maximum tolerated dose of multiple doses, which provides the basis for the formulation of phase I pharmacokinetic studies and phase II clinical trial dosing schedules.