Shaojie Guo, Yingchun Hu, Chengshuo Wang, Yuan Zhang, Feng Wu, Siyang Ni, Yuyang Dai, Ying Han, Minwan Hu, Chunping Lu, Zhijian Xi, Laichun Lu, Xiuli Zhao, Luo Zhang
OBJECTIVE: PA9159 (previously named VSG159) is a structurally novel and highly potent glucocorticoid that plays a role in the late development of autoimmune and inflammatory diseases. The current first-in-human ascending-dose study of the PA9159 nasal spray was conducted in healthy Chinese volunteers to evaluate its pharmacokinetics, safety, and tolerability. In addition, the effects of PA9159 on serum cortisol secretion were investigated. METHODS: This was a double-blinded, randomized, placebo-controlled clinical study that included four single-dose groups in the single ascending dose cohort (SAD) and two multiple-dose groups in the multiple ascending dose cohort (MAD), with dose ranges of 10-80 μg and 20-40 μg, respectively...
April 8, 2024: European Journal of Pharmaceutical Sciences