Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Atherosclerosis; Cardiovascular Disease
• Interventions: Biological: MEDI6570; Biological: Part B Placebo; Biological: Placebo

• Registration Number: NCT03654313
• Lead Sponsor: MedImmune LLC

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

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-09-28
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A MEDI6570 Cohort 4	MEDI6570	Part A MEDI6570 Cohort 4 dose level
Part B MEDI6570 Cohort 3	MEDI6570	Part B MEDI6570 Cohort 3 dose level
Part A MEDI6570 Cohort 3	MEDI6570	Part A MEDI6570 Cohort 3 dose level
Part A MEDI6570 Cohort 1	MEDI6570	Part A MEDI6570 Cohort 1 dose level
Part A MEDI6570 Cohort 6	MEDI6570	Part A MEDI6570 Cohort 6 dose level
Part B Placebo	Part B Placebo	Part B Placebo
Part A MEDI6570 Cohort 5	MEDI6570	Part A MEDI6570 Cohort 5 Dose level
Part A MEDI6570 Cohort 2	MEDI6570	Part A MEDI6570 Cohort 2 dose level
Part B MEDI6570 Cohort 2	MEDI6570	Part B MEDI6570 Cohort 2 dose level
Part A Placebo	Placebo	Part A Placebo
Part B MEDI6570 Cohort 1	MEDI6570	Part B MEDI6570 Cohort 1 dose level

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability of MEDI6570	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 Outcome Measures

Name	Time	Method
Immunogenicity rate	Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)	ADA incidence rate and titer will be tabulated for each treatment group. Samples confirmed positive for ADA will be tested and analyzed for nAB titer and summarized similarly.
Pharmacokinetics of MEDI6570 Tmax	Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)	Non-compartmental analysis will be performed for MEDI6570 treated subjects. Descriptive statistics for PK parameters will be provided
Pharmacokinetics of MEDI6570 AUC	Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)	Non-compartmental analysis will be performed for MEDI6570 treated subjects. Descriptive statistics for PK parameters will be provided
Pharmacokinetics of MEDI6570 Cmax	Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)	Non-compartmental analysis will be performed for MEDI6570 treated subjects. Descriptive statistics for PK parameters will be provided
Pharmacokinetics of MEDI6570 Terminal Half life	Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)	Non-compartmental analysis will be performed for MEDI6570 treated subjects. Descriptive statistics for PK parameters will be provided

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States