Ewa Gatlik, Beata Mehes, Emilie Voltz, Ulrike Sommer, Elaine Tritto, Giulia Lestini, Xiaoxi Liu, Parasar Pal, Maria Velinova, Wiliam S Denney, Yunlin Fu, Anthony Opipari, Dennis Dean, Guido Junge
This first-in-human study evaluated the safety, tolerability, single- and multiple-dose pharmacokinetic profiles with dietary influence, and pharmacodynamics (PD) of DFV890, an oral NLRP3 inhibitor, in healthy participants. In total, 122 participants were enrolled into a three-part trial including single and 2-week multiple ascending oral doses (SAD and MAD, respectively) of DFV890, and were randomized (3:1) to DFV890 or placebo (SAD [3-600 mg] and MAD [fasted: 10-200 mg, once-daily or fed: 25 and 50 mg, twice-daily])...
May 2024: Clinical and Translational Science