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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394314
• Other study ID #: D5670C00001
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2015
• Last updated: September 8, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• MEDI0382
MEDI0382 administered subcutaneously
• Placebo
Placebo administered subcutaneously

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)	This variable will be estimated for MEDI0382 where the data allow.	72 hours postdose	No
Secondary	Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)	This variable will be estimated for MEDI0382 where the data allow.	72 hours post dose	No
Secondary	Proportion of subjects with ADA to MEDI0382	This variable will be estimated for MEDI0382 where the data allow.	28 days post dose	Yes