Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM
NCT02581657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2018-04-10
Summary
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 type 2 diabetes mellitus (T2DM) in up to four cohorts.
Conditions
Interventions
- DRUG
-
PE0139 Injection
PE0139 Injection
- DRUG
-
Placebo Injection
Placebo Injection
Sponsors & Collaborators
-
PhaseBio Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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