[Translation] A randomized, phase II/III study to evaluate the efficacy, safety, and tolerability of elacycline compared with moxifloxacin in the treatment of adult subjects with community-acquired bacterial pneumonia (CABP)
阶段1:综合评价依拉环素两个不同给药剂量和频次在CABP受试者的安全性、有效性和药代动力学特征,根据以上结果综合评估并确定阶段2中依拉环素组的给药剂量和频次。 阶段2:
主要目的:评价依拉环素与莫西沙星的mITT人群在TOC访视时的临床疗效
次要目的:
评价依拉环素组与莫西沙星组的
i.ITT和CE人群在TOC访视时的临床疗效
ii.ITT和mITT人群的早期临床应答(ECR)
iii.ITT、mITT和CE人群在EOT访视的临床疗效
iv.m-mITT和ME人群在EOT和TOC访视时的微生物学疗效和综合疗效
v.安全性分析人群中的安全性和耐受性 探索性目的:评价依拉环素组与莫西沙星组mITT、CE人群中在首剂给药后28天内的全因死亡率
[Translation] Phase 1: Comprehensively evaluate the safety, efficacy and pharmacokinetic characteristics of two different dosing doses and frequencies of elacycline in CABP subjects, and comprehensively evaluate and determine the dosing dose and frequency of the elacycline group in Phase 2 based on the above results. Phase 2:
Primary purpose: To evaluate the clinical efficacy of elacycline and moxifloxacin in the mITT population at the TOC visit
Secondary purpose:
To evaluate the clinical efficacy of elacycline group and moxifloxacin group
i. Clinical efficacy of ITT and CE populations at the TOC visit
ii. Early clinical response (ECR) of ITT and mITT populations
iii. Clinical efficacy of ITT, mITT and CE populations at the EOT visit
iv. Microbiological efficacy and comprehensive efficacy of m-mITT and ME populations at the EOT and TOC visits
v. Safety and tolerability in the safety analysis population Exploratory purpose: To evaluate the all-cause mortality rate in the mITT and CE populations of elacycline group and moxifloxacin group within 28 days after the first dose.