Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS ‐CoV‐2 neutralizing monoclonal antibody ABBV‐47D11 in patients with COVID‐19
Left: CONSORT flow chart. Right: ABBV-47D11 Dose –Response for SARS-CoV-2 Viral Load AUC of Change from Baseline to Day 15. AUC: area under the curve; Box plots represent 25th/75th percentiles, median (solid line), mean (dashed line), whiskers represent min-max values, and dots represent individual patient data. AbstractABBV-47D11 is a neutralizing monoclonal antibody that targets a mutationally conserved hydrophobic pocket distal to the ACE2 binding site of SARS-CoV-2. This first-in-human safety, pharmacokinetics, and antiviral pharmacodynamic assessment in patients with COVID-19 provide an initial evaluation of this antibody that may allow further development. This multicenter, randomized, double-blind, and placebo-controlled single ascending dose study of ABBV-47D11 (180, 600, or 2400 mg) as an intravenous infusion, was in hospitalized and non-hospitalized (confined) adults with mild to moderate COVID-19. Primary outcomes were grade 3 or higher study drug-related adverse events and infusion-related reactions. Secondary outcomes were pharmacokinetic parameters and concentration -time profiles to Day 29, immunogenicity (anti-drug antibodies), and antiviral activity (change in RT-PCR viral load) from baseline to Days 15 and 29. ABBV-47D11 single doses up to 2400 mg were safe and tolerated and no safety signals were identified. The pharmacokinetics of ABBV-47D11 were linear and showed dose-proportional increases in serum concentrations with ascending doses. The explorat...
Source: Pharmacology Research and Perspectives - Category: Drugs & Pharmacology Authors: Mohamad Shebley,
Stanley Wang,
Izna Ali,
Preethi Krishnan,
Rakesh Tripathi,
Joseph M. Reardon,
John Cafardi,
Galia Rahav,
Yoseph Caraco,
Jihad Slim,
Fadi Al Akhrass,
Mengjia Yu,
Yiran Hu,
Rosa De Abreu Ferreira,
Negar N. Alami Tags: ORIGINAL ARTICLE Source Type: research