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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	PE0139 Injection
DRUG	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-04-19
• Last updated: 2014-10-15

Locations

3 sites across 1 country: United States