Clinical trial NCT02394314: A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
Official title: A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: MEDI0382, diabetes
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
timeFrame: 28 days post dosing
measure: Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
timeFrame: 28 days post dosing
measure: Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
timeFrame: 28 days post dosing
measure: Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
timeFrame: 28 days post dosing
measure: Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
timeFrame: 28 days post dosing
Secondary outcomes:
measure: Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)
timeFrame: 72 hours postdose
measure: Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)
timeFrame: 72 hours post dose
measure: Proportion of subjects with ADA to MEDI0382
timeFrame: 28 days post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
References: