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This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PE0139 Injection | Experimental | Single subcutaneous injection of PE0139, 40 mg/mL |
|
| Placebo | Placebo Comparator | Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PE0139 Injection | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vital Signs from baseline (Day 0 Pre-dose) | Safety will be evaluated by analyses of the change from baseline in vital signs. | Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 |
| Change in ECGs from baseline (Day -1) | Safety will be evaluated by analyses of the change from baseline in 12-lead ECG. | ECG Days 2 and 28 |
| Change in Safety Labs from baseline (Pre-dose) | Safety will be evaluated by analyses of the safety laboratory parameters. | Safety Labs Days 0, 7 and 28 |
| Incidence and severity of immunogenicity | Safety will be evaluated by the incidence and severity of immunogenicity. | Immunogenicity Days 0, 7, 14 and 28 |
| Incidence and severity of adverse events including hypoglycemia | Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia. | As reported between Days -10 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profile | Pharmacokinetic parameters include: Area under the concentration curve from time 0 to infinity (AUC(0-inf)), Area under the concentration curve to the final sample with a concentration greater than or equal to Limit of Quantitation (LOQ) (AUC(0-t)), Time to maximum concentration (Tmax), Maximum serum concentration (Cmax), Elimination rate constant (Lambda-z), Elimination half-life (t1/2), Clearance uncorrected for bioavailability (CL/F), Distribution uncorrected for bioavailability (Vz/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Brazg, MD | Rainier Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Palm Springs Research Institute |
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|
| Day 0, 1, 2, 3, 4, 5, 6, and 7 |
| Pharmacodynamic Response | To assess the pharmacodynamic response (time action profile) of various single doses of PE0139. Assessments include Fasting plasma glucose (FPG), 4-point serial glucose monitoring and glucose assessed by continuous glucose monitoring (CGM). | FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7 |
| Hialeah |
| Florida |
| 33012 |
| United States |
| Rainier Clinical Research | Renton | Washington | 98057 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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