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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: MEDI0382

• Registration Number: NCT02394314
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered subcutaneously
MEDI0382	MEDI0382	MEDI0382 administered subcutaneously

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382	28 days post dosing	Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382	28 days post dosing	Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany