Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| MEDI0382 | Experimental | MEDI0382 administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI0382 | Drug | MEDI0382 administered subcutaneously |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax) | This variable will be estimated for MEDI0382 where the data allow. | 72 hours postdose |
| Pharmacokinetics of MEDI0382, area under the curve concentration (AUC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624433 | cotadutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo administered subcutaneously |
|
This variable will be estimated for MEDI0382 where the data allow.
| 72 hours post dose |
| Proportion of subjects with ADA to MEDI0382 | This variable will be estimated for MEDI0382 where the data allow. | 28 days post dose |