drugset / Trial / NCT03072407

MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

NCT03072407

Phase 1 Completed 40 enrolled PegBio Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.

Timeline

Start
2015-11-24
Primary completion
2016-11-02
Completion
2016-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PB-119 Peptide 25 ug Subcutaneous
Subject PB-119 Peptide 50 ug Subcutaneous
Subject PB-119 Peptide 100 ug Subcutaneous
Subject PB-119 Peptide 200 ug Subcutaneous