A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus.

MedImmune LLC1 site in 1 country88 target enrollmentSeptember 28, 2018

ConditionsAtherosclerosis Cardiovascular Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Atherosclerosis
Sponsor: MedImmune LLC
Enrollment: 88
Locations: 1
Primary Endpoint: Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability of MEDI6570
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus

Detailed Description

A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects with Type 2 Diabetes Mellitus

Registry

clinicaltrials.gov

Start Date

September 28, 2018

End Date

July 21, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability of MEDI6570

Time Frame: Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)

Measured by the incidence of treatment- emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

Secondary Outcomes

Immunogenicity rate(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
Pharmacokinetics of MEDI6570 Tmax(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
Pharmacokinetics of MEDI6570 AUC(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
Pharmacokinetics of MEDI6570 Cmax(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
Pharmacokinetics of MEDI6570 Terminal Half life(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))