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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: MEDI0382

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.

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered subcutaneously	Drug: Placebo; Placebo administered subcutaneously
Experimental: MEDI0382; MEDI0382 administered subcutaneously	Drug: MEDI0382; MEDI0382 administered subcutaneously

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

Collaborators and Investigators

• Sponsor: MedImmune LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: MEDI0382, diabetes
• Other Study ID Numbers: D5670C00001