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This first\u2010in\u2010human safety, pharmacokinetics, and antiviral pharmacodynamic assessment in patients with COVID\u201019 provide an initial evaluation of this antibody that may allow further development. This multicenter, randomized, double\u2010blind, and placebo\u2010controlled single ascending dose study of ABBV\u201047D11 (180, 600, or 2400\u2009mg) as an intravenous infusion, was in hospitalized and non\u2010hospitalized (confined) adults with mild to moderate COVID\u201019. Primary outcomes were grade 3 or higher study drug\u2010related adverse events and infusion\u2010related reactions. Secondary outcomes were pharmacokinetic parameters and concentration\u2010time profiles to Day 29, immunogenicity (anti\u2010drug antibodies), and antiviral activity (change in RT\u2010PCR viral load) from baseline to Days 15 and 29. ABBV\u201047D11 single doses up to 2400\u2009mg were safe and tolerated and no safety signals were identified. The pharmacokinetics of ABBV\u201047D11 were linear and showed dose\u2010proportional increases in serum concentrations with ascending doses. The exploratory anti\u2010SARS\u2010CoV\u20102 activity revealed a reduction of viral load at and above the 600\u2009mg dose of ABBV\u201047D11 regardless of patient demographics and baseline characteristics, however; because of the high inter\u2010individual variability and small sample size a statistical significance was not reached. There is potential for anti\u2010SARS\u2010CoV\u20102 activity with ABBV\u201047D11 doses of 600\u2009mg or higher, which could be evaluated in future clinical trials designed and powered to assess viral load reductions and clinical benefit.<\/jats:p>","DOI":"10.1002\/prp2.1036","type":"journal-article","created":{"date-parts":[[2022,12,20]],"date-time":"2022-12-20T10:35:47Z","timestamp":1671532547000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Phase 1 study of safety, pharmacokinetics, and antiviral activity of <scp>SARS\u2010CoV<\/scp>\u20102 neutralizing monoclonal antibody <scp>ABBV\u201047D11<\/scp> in patients with <scp>COVID<\/scp>\u201019"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0147-8933","authenticated-orcid":false,"given":"Mohamad","family":"Shebley","sequence":"first","affiliation":[{"name":"AbbVie Inc.  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