NCT02084251

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

Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
DRUG	PB-119

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-03-11
• Last updated: 2017-02-14

Locations

1 site across 1 country: China