[Translation] Randomized, open, multicenter, phase IIa clinical study of JDB0131 besylate tablets on early bactericidal activity, safety, tolerability and pharmacokinetic characteristics of drug-sensitive pulmonary tuberculosis patients
主要目的:
评估JDB0131 苯磺酸盐片在药物敏感性肺结核患者体内早期杀菌活性;探索最佳有效剂量,为IIb 期临床试验提供依据。
次要目的:
1、评估JDB0131 苯磺酸盐片多次给药后在药物敏感性肺结核患者体内安全性和耐受性;
2、评估JDB0131 苯磺酸盐片多次给药后在药物敏感性肺结核患者体内的药代动力学特征。
[Translation] main purpose:
Evaluate the early bactericidal activity of JDB0131 besylate tablets in drug-sensitive pulmonary tuberculosis patients; explore the optimal effective dose to provide a basis for phase IIb clinical trials.
Secondary purpose:
1. To evaluate the safety and tolerability of JDB0131 besylate tablets in patients with drug-sensitive pulmonary tuberculosis after multiple administrations;
2. To evaluate the pharmacokinetic characteristics of JDB0131 besylate tablets in drug-sensitive pulmonary tuberculosis patients after multiple administrations.