Clinical Trial for PB-119 in Healthy Subjects (Phase I)

Summary

GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.

Timeline

Start

2014-02

Primary completion

2014-11

Completion

2014-11

Publications

• Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Li Y, Xia YH, Liu Y, Tian JH, Zhang P. Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2020 Jun;45(3):361-369. doi: 10.1007/s13318-020-00605-9.

Drugs

Indications