DRUG
MEDI0382
MEDI0382 administered subcutaneously
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
Status
Completed
Phase
Phase 1
Enrollment
362
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo administered subcutaneously
Timeline
From registration to results.
First posted
Mar 20, 2015
Study start
Feb 2015
Primary completion
Aug 2015
Study completion
Aug 2015
Results posted
Not reported
Registry updated
Sep 9, 2015
Outcomes
What the study measures.
Primary outcomes
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
Time frame · 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
Time frame · 28 days post dosing
GI symptomatology (a composite of nausea and vomiting)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame · 28 days post dosing
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame · 28 days post dosing
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame · 28 days post dosing
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
Secondary outcomes
Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)
Time frame · 72 hours postdose
This variable will be estimated for MEDI0382 where the data allow.
Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)
Time frame · 72 hours post dose
This variable will be estimated for MEDI0382 where the data allow.
Proportion of subjects with ADA to MEDI0382
Time frame · 28 days post dose
This variable will be estimated for MEDI0382 where the data allow.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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 locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Berlin, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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