Clinical Trial for PB-119 in Healthy Subjects (Phase I)
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.