A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.

Detailed Description
-----------------
This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.

Official Title
-----------------
A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: MEDI0382
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers, ages 18-45 Must provide written informed consent BMI >22 and <30 kg/m2 and body weight >70kg 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 non-melanoma skin cancer 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. Concurrent or previous use of a GLP-1 receptor agonist 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 control of body weight or appetite is prohibited. Known or suspected history of alcohol or drug abuse within the past 3 years. Positive drug screen Current smoker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo administered subcutaneously | Drug: Placebo<br>* Placebo administered subcutaneously<br>|
| Experimental: MEDI0382<br>MEDI0382 administered subcutaneously | Drug: MEDI0382<br>* MEDI0382 administered subcutaneously<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 | Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs) | 28 days post dosing | 
| Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382 | GI symptomatology (a composite of nausea and vomiting) | 28 days post dosing | 
| Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382 | Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate) | 28 days post dosing | 
| Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382 | 12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals | 28 days post dosing | 
| Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382 | Clinical laboratory assessments (serum chemistry, hematology, urinalysis) | 28 days post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax) | This variable will be estimated for MEDI0382 where the data allow. | 72 hours postdose | 
| Pharmacokinetics of MEDI0382, area under the curve concentration (AUC) | This variable will be estimated for MEDI0382 where the data allow. | 72 hours post dose | 
| Proportion of subjects with ADA to MEDI0382 | This variable will be estimated for MEDI0382 where the data allow. | 28 days post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MEDI0382, diabetes