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

NCT ID: NCT02394314

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo administered subcutaneously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered subcutaneously

MEDI0382

MEDI0382 administered subcutaneously

Group Type: EXPERIMENTAL

MEDI0382

Intervention Type: DRUG

MEDI0382 administered subcutaneously

Interventions

MEDI0382

MEDI0382 administered subcutaneously

Intervention Type: DRUG

Placebo

Placebo administered subcutaneously

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D5670C00001

Identifier Type: -

Identifier Source: org_study_id