| Outcome Measures: |
Primary: Time to plasma glucose recovery, Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous glucose, 0-45 minutes after dosing | Secondary: Plasma glucose changes from baseline, Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue patient level)., 0-30 minutes after dosing|Pharmacodynamics - Area under the effect curve 30 min, Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min, 0-30 minutes after dosing|Pharmacodynamics - Area under the effect curve 90 min, Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min, 0-90 minutes after dosing|Pharmacodynamics - Maximum plasma glucose concentration, Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax, 0-90 minutes after dosing|Pharmacodynamics - Time maximum plasma glucose concentration, Time to maximum change in plasma glucose measure from baseline, TEmax, 0-90 minutes after dosing|Pharmacokinetics - Area under the plasma concentration-time curve 30 min, Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min, 0-30 minutes after dosing|Pharmacokinetics - Area under the plasma concentration-time curve 300 min, Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min, 0-300 minutes after dosing|Pharmacokinetics - Area under the plasma concentration curve Infinitely, Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf, 0-300 minutes after dosing|Pharmacokinetics - Maximum plasma concentration, Measured maximum plasma drug concentration after dosing, Cmax, 0-300 minutes after dosing|Pharmacokinetics - Time to maximum plasma concentration, Sampling time until reaching Cmax, Tmax, 0-300 minutes after dosing|Pharmacokinetics - Half-life, Half-life dasiglucagon, t½, 0-300 minutes after dosing|Pharmacokinetics - Volume of distribution, Apparent volume of distribution of dasiglucagon, Vz/f, 0-300 minutes after dosing|Pharmacokinetics - Mean residence time, Mean residence time, MRT, 0-300 minutes after dosing|Pharmacokinetics - Body clearance, Total body clearance, CL/f, 0-300 minutes after dosing|Safety - Adverse events, The incidence, type and severity of adverse events (AEs), 90 days|Safety - Number of rescue infusions, Number of rescue infusions of IV glucose after trial drug administration, 0-90 minutes after dosing|Safety - Time to first rescue infusion, Time to first rescue infusion of IV glucose after trial drug administration, 0-90 minutes after dosing|Immunogenicity - Occurrence of anti-drug antibodies, Occurrence of antibodies against dasiglucagon, 60 days
|
