Healthy Volunteers
Conditions
Keywords
MEDI0382, diabetes
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.
Interventions
DRUGMEDI0382
MEDI0382 administered subcutaneously
DRUGPlacebo
Placebo administered subcutaneously
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | GI symptomatology (a composite of nausea and vomiting) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed