Fortrea Pharmaceutical Research & Dev (Beijing) Co. Ltd.

Primary objectives: To demonstrate that cefepime-zidebactam (FEP-ZID) is non-inferior to meropenem in terms of: Overall success rate (clinical cure + microbiological eradication rate) in the microbiological modified intention-to-treat (mMITT) population at the check-of-cure (TOC) visit; To assess the overall safety and tolerability of FEP-ZID in the safety population; Secondary objectives: To assess the overall efficacy in the clinically evaluable (CE) and microbiologically evaluable (ME) populations at TOC; To assess the overall efficacy in the mMITT population at the end of treatment (EOT); To assess the overall efficacy of FEP-ZID in the EOT (mMITT population) and TOC (mM =To evaluate the clinical outcomes at EOT (mMITT population) and TOC (mMITT, CE and ME populations); To evaluate the overall efficacy by pathogen at TOC (mMITT, CE and ME populations) and the clinical outcomes (mMITT and CE populations) and microbiological outcomes (mMITT and ME populations) by pathogen; To evaluate the clinical outcomes in the mMITT population at late follow-up (LFU); To evaluate the pharmacokinetics (PK) of FEP-ZID in adult subjects with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP);

The primary objectives of this study are: To evaluate the pharmacokinetics (PK) of a single intravenous (IV) dose of 3 g cefepime-zidebactam (FEP-ZID) in healthy Chinese subjects. The secondary objectives of this study are: To evaluate the safety and tolerability of a single IV dose of 3 g FEP-ZID in healthy Chinese subjects.

Primary Objectives: To assess whether abelacimab is superior to placebo in reducing the risk of ischemic stroke or systemic embolism (SE) in patients with AF who are considered ineligible for oral anticoagulation. Secondary Objectives: To assess the composite endpoint of ischemic stroke, SE, myocardial infarction (MI), venous thromboembolism (VTE), or acute limb ischemia comparing abelacimab to placebo. To assess the net clinical outcome, defined as the composite endpoint of ischemic stroke, SE, or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding, comparing abelacimab to placebo. To assess cardiovascular mortality and all-cause mortality comparing abelacimab to placebo. To assess the net clinical outcome, defined as the composite endpoint of ischemic stroke, SE, MI, VTE, acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding, comparing abelacimab to placebo. Primary Safety Objectives: To assess the risk of bleeding comparing abelacimab to placebo.