Safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity profiles of Exendin-4-IgG4-Fc in healthy subjects: A phase 1, single-centre, randomized, double-blind, dose escalation study.

Gui-Ling ChenYang LiuXue-Feng GaoKai-Qi WuYun-Kai YangYong ChenCong-Gao PengTing-Han JinYu-Bao HuangYao-Wen ZhangJing SuQi JiangTong GuoJie ZhaoXiang-Nan PengJing-Yu PengSi-Xiu LiYong-Li SunHong-Mei ZhangYan-Li FuDan LuoYaru MaZhen-Wei ShenYun-Tao ZhangZhang-Fei Shou

Published in: Diabetes, obesity & metabolism (2024)

E4F4 exhibited an acceptable safety profile and linear pharmacokinetics in healthy subjects. The recommended phase 2 dose is 4.5-10.35 mg once every 2 weeks.

Keyphrases

double blind
placebo controlled
open label
phase iii
clinical trial
phase ii
study protocol
randomized controlled trial
gestational age
preterm birth