A Randomized Placebo-Controlled Double-Blind Sponsor Unblinded Single Ascending Dose Phase 1 First in Human Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for

Brief description of study

The global spread of the SARS-CoV-2 virus has resulted in the current pandemic of COVID-19 disease, which in critical cases results in progressive pulmonary failure, acute respiratory distress syndrome (ARDS) and even death. The purpose of this study is to test LY3819253 as a potential new drug for the treatment of COVID-19 disease. LY3819253 is an investigational drug. “Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug for research. This study is the first study with LY3819253 in humans. Due to the urgency related to the COVID-19 outbreak, the study drug has not yet been tested in animals and the animal studies with LY381953 will be conducted in parallel with this first in human study.

Clinical Study Identifier: s20-00801
ClinicalTrials.gov Identifier: NCT04411628

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