Abstract
Interleukin-13 (IL-13) is a key mediator of T-helper-cell-type-2 (Th-2)-driven asthma, the inhibition of which may improve treatment outcomes. We examined the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of VR942, a dry-powder formulation containing CDP7766, a high-affinity anti-human-IL-13 antigen-binding antibody fragment being developed for the treatment of asthma. We conducted a phase 1, randomized, double-blind, placebo-controlled, ascending-dose study at Hammersmith Medicines Research, London, UK, which is now complete. Healthy adults aged 18-50 years (n = 40) were randomized 3:1 to a single inhaled dose of VR942 0.5, 1.0, 5.0, 10, or 20 mg, or placebo. Adults aged 18-50 years who were diagnosed with asthma for ≥6 months before screening, and had forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) values ≥70% of the predicted values at screening (n = 45), were randomized to once-daily inhaled VR942 0.5 or 10 mg, or placebo (2:2:1), or VR942 20 mg or placebo (3:2), for 10 days. All participants were randomized to receive VR942 or placebo based on a randomization list prepared by an independent HMR statistician using SAS® software (SAS Institute, Cary, NC). The primary outcome was safety...Continue Reading
Citations
Feb 15, 2019·The European Respiratory Journal·Parameswaran Nair, Paul M O'Byrne
Sep 3, 2020·Nature Reviews. Drug Discovery·Misty M AttwoodHelgi B Schiöth
Sep 4, 2020·International Journal of Molecular Sciences·Annamaria SandomenicoMenotti Ruvo
Oct 30, 2020·Pharmaceutics·Wanling LiangJenny K W Lam
Jan 9, 2021·Expert Opinion on Drug Delivery·Maria Gabriella MateraMario Cazzola
Dec 15, 2020·Advanced Drug Delivery Reviews·Carlos Cruz-TeranSamuel K Lai
Mar 3, 2021·Cell Reports Medicine·Michael S PiepenbrinkJames J Kobie
Mar 12, 2021·Advanced Drug Delivery Reviews·Yajie ZhangRobert O Williams
Apr 15, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Eleonore Fröhlich, Sharareh Salar-Behzadi
Mar 22, 2021·The Journal of Allergy and Clinical Immunology·Irene E BraithwaiteHubert Chen
Jun 10, 2021·Clinical and Translational Science·Thomas SouthworthDave Singh
Jun 19, 2021·AAPS PharmSciTech·Basanth Babu EedaraHeidi M Mansour
May 29, 2019·Respiratory Medicine·Maria Gabriella MateraMario Cazzola
Aug 24, 2021·Applied Microbiology and Biotechnology·Hilal Ahmad ParrayRajesh Kumar
Sep 2, 2021·AAPS PharmSciTech·Kimberly B ShepardMichael Banks
Sep 22, 2021·International Journal of Pharmaceutics·Ashutosh SharmaHelen Hughes
Oct 20, 2021·The Cochrane Database of Systematic Reviews·Andrew GallagherDavid Jw Evans