A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
NCT02211261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2018-10-16
Summary
A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
Conditions
Interventions
- BIOLOGICAL
-
PF-06293620
subcutaneous, single dose 0.3 mg/kg
- BIOLOGICAL
-
Subcutaneous normal saline single dose
- BIOLOGICAL
-
PF-06293620
Subcutaneous, single dose 1.0 mg/kg
- BIOLOGICAL
-
Subcutaneous normal saline single dose
- BIOLOGICAL
-
PF-06293620
Subcutaneous single dose 3 mg/kg
- BIOLOGICAL
-
Subcutaneous normal saline single dose
- BIOLOGICAL
-
PF-06293620
Subcutaneous single dose 6 mg/kg
- BIOLOGICAL
-
Subcutaneous normal saline single dose
- BIOLOGICAL
-
PF-06293620
Intravenous infusion single dose 1 mg/kg
- BIOLOGICAL
-
Intravenous infusion normal saline single dose
- BIOLOGICAL
-
PF-06293620
Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
- BIOLOGICAL
-
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
- BIOLOGICAL
-
PF-06293620
Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
- BIOLOGICAL
-
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
- BIOLOGICAL
-
PF-06293620
Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
- BIOLOGICAL
-
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
- BIOLOGICAL
-
PF-06293620
Subcutaneous injection multiple dose TBD mg (Days TBD)
- BIOLOGICAL
-
Subcutaneous injection normal saline multiple dose (Days TBD)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-15
- Primary Completion
- 2017-01-27
- Completion
- 2017-01-27
Countries
- United States
Study Locations
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