drugset / Trial / NCT01835730

Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

NCT01835730 ↗

Phase 1 Completed 37 enrolled PhaseBio Pharmaceuticals Inc.
RandomizedSingle-groupQuadruple-blindTreatment

Summary

This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).

Timeline

Start
2013-04
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PE0139 Unknown 40 mg/ml Subcutaneous