Continuous Multiple Dose PB-119 Injection in Health Volunteers

Summary

This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will be performed at the same time with tolerability study. Three dose arms are designed, 12 subjects will be enrolled in each arm, will equal number of males and females.

Timeline

Start

2014-11-15

Primary completion

2016-09-13

Completion

2016-10-08

Publications

• Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Ma XZ, Xia YH, Tian JH, Ma Y, Liu Y, Zhang P, Xu M. Safety, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Doses of PEGylated Exenatide (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):265-275. doi: 10.1007/s13318-020-00665-x. Epub 2021 Feb 12.

Drugs

Indications