A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

MedImmune LLC103 enrolled

Overview

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).

This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

103

Conditions

Type 2 Diabetes

Interventions

MEDI-4166BIOLOGICAL

MEDI-4166 administered subcutaneously

PlaceboBIOLOGICAL

Placebo administered subcutaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes, ages 18-65 * Must provide written informed consent * BMI\>=25 and =\<42 * Venous access suitable for multiple cannulations * Vital signs within normal specified ranges * Females must be non-lactating and non-childbearing potential * Males must practice 2 effective contraceptive measures if sexually active Exclusion Criteria: * Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * History of cancer, with the exception of basal cell carcinoma or carcinoma of the cervix * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing * Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening * Current or previous use of systemic corticosteroids within the past 28 days prior to screening * Use of any medicinal products or herbal preparations licensed for weight loss is prohibited. * Positive drug screen * Type 1 diabetes

Locations (11)

Research Site

Anniston, Alabama, United States

Research Site

Chula Vista, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Outcomes

Primary Outcomes

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

Time frame: 43 days post dosing

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

Time frame: 43 days post dosing

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

Time frame: 43 days post dosing

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

Time frame: 43 days post dosing

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Physical examination

Time frame: 43 days post dosing

Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

Time frame: 36 days post dosing

Part B: Change in LDL-C from baseline to Day 36

Time frame: 36 days post dosing

Secondary Outcomes

Data from ClinicalTrials.gov

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Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

Time frame: 43 days post dosing

Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

Time frame: 43 days post dosing

Part A: Change from baseline in LDL-C

Time frame: 43 days post dosing

Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166

Part A: Proportion of subjects with ADA to MEDI4166

Time frame: 43 days post dosing

Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

Time frame: 71 days post dosing

Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

Time frame: 71 days post dosing

Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

Time frame: 71 days post dosing

Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

Time frame: 71 days post dosing

Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

Physical examination

Time frame: 71 days post dosing

Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

Time frame: 71 days post dosing

Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

Time frame: 71 days post dosing

Part B: Change from baseline in fructosamine levels

Time frame: 36 days post dosing

Part B: Proportion of subjects with ADA to MEDI4166

Time frame: 71 days post dosing

Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

Time frame: 43 days post dosing

Part A: Change from baseline in glucose AUC up to 240 minutes

Time frame: 43 days post dosing

Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

Time frame: 71 days post dosing