| Outcome Measures: |
Primary: 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 | Secondary: 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), 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
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| Locations: |
Pinnacle Research Group, LLC, Anniston, Alabama, 36207, United States|Palm Springs Research Institute, Hialeah, Florida, 33012, United States|Rainier Clinical Research, Renton, Washington, 98057, United States
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