Study to Assess the Safety, Tolerability, PK & PD Response of PE0139

Status Completed

Clinical Trial Summary

Clinical Trial Description

This study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with T2DM in up to four cohorts; (6 active/2 placebo subjects in cohort 1, and up to 9 active/4 placebo in each subsequent cohort).

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic response of PE0139 in the presence of existing stable non-insulin antidiabetic background therapy. Subjects will return weekly for a total of 6 doses of study drug.

Study remains active, not recruiting as subjects who received active study drug will be followed for secondary outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02581657
Study type	Interventional
Source	PhaseBio Pharmaceuticals Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	October 2015
Completion date	November 2016

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Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms