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A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction

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Trial Profile

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2023

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At a glance

  • Drugs CSL 112 (Primary)
  • Indications Myocardial infarction
  • Focus Adverse reactions
  • Acronyms AEGIS-I
  • Sponsors CSL Behring

    • Most Recent Events

    • 01 Jun 2023 Results (n=50) assessing the effects of CSL112 (human APOA1 [apolipoprotein A1]) on the APOA1 exchange rate (AER) and the relationships with specific HDL (high-density lipoprotein) subpopulations when administered in the 90-day high-risk period post-acute myocardial infarction published in the Arteriosclerosis Thrombosis and Vascular Biology
    • 04 Apr 2022 Data from 5 clinical trials (single and multiple ascending dose phase 1 studies in healthy volunteers, a phase 2a study in subjects with stable atherosclerotic disease, a phase 2b study in subjects post-AMI (AEGIS-I), and a phase 1 Japanese ethno-bridging study) assessing pharmacokinetics (PK) and pharmacodynamics (PD) of CSL112 across different populations, presented at the 71st Annual Scientific Session of the American College of Cardiology.
    • 15 Nov 2017 Results of substudy (n=63) presented at the 90th Annual Scientific Sessions of the American Heart Association

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