Lyrialle W Han, Samira Jamalian, Joy C Hsu, X Rebecca Sheng, Xiaoyun Yang, Xiaoying Yang, Sharareh Monemi, Sharmeen Hassan, Rajbharan Yadav, Katie Tuckwell, Rebecca Kunder, Lin Pan, Sara Glickstein
INTRODUCTION: Transforming growth factor beta (TGFβ) cytokines (TGFβ1, TGFβ2, and TGFβ3) play critical roles in tissue fibrosis. However, treatment with systemic pan-TGFβ inhibitors have demonstrated unacceptable toxicities. In this study, we evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7303509, a high-affinity, TGFβ3-specific, humanized immunoglobulin G1 monoclonal antibody, in healthy adult volunteers (HVs). METHODS: This phase 1a, randomized, double-blind trial included six cohorts for evaluation, with each cohort receiving single doses of placebo or RO7303509, administered intravenously (IV; 50 mg, 150 mg, 240 mg) or subcutaneously (SC; 240 mg, 675 mg, 1200 mg)...
April 25, 2024: Rheumatology and Therapy