Outcome Measures: |
Primary: Absolute bioavailability of the high and the low concentration cotadutide SC formulations, Evaluation of the absolute bioavailability (F) of the SC formulations by comparison of AUCsubcut/AUCIV, Collection of plasma samples from pre-dose to 72 hours post-dose.|Maximum observed concentration (cmax), Assessment of pharmacokinetics and relative bioavailability of cotadutide solution for injection by measuring maximum observed concentration (cmax), Collection of plasma samples from pre-dose to 72 hours post-dose.|Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state, Pharmacokinetic parameters AUC0-t for cotadutide in the high concentration and low concentration regimens, Collection of plasma samples from pre-dose to 72 hours post-dose.|Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state, Pharmacokinetic parameters AUC0-inf for cotadutide in the high concentration and low concentration regimens, Collection of plasma samples from pre-dose to 72 hours post-dose. | Secondary: Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters tmax, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters Cmax, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters AUC0-t, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters AUC0-inf, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters t1/2, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters λz, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters CL (IV dose), for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters CL/F, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters Vz, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters Vz/F, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Provide additional details on the single dose PK of cotadutide, Pharmacokinetic parameters MRTinf, for cotadutide, as applicable, Collection of plasma samples from pre-dose to 72 hours post-dose.|Number of adverse events (AEs) experienced by subjects, Safety and tolerability assessed through the incidence of AEs, Collection of plasma samples from pre-dose to 72 hours post-dose.|Evaluate immunogenicity for cotadutide administered as low and high concentration SC formulations and an IV formulation, ADA incidence and titre, Collection of plasma samples from pre-dose to 72 hours post-dose. | Other: To collect data on the size and shape of SC injection, Measurement of thermal image of the injection point before and immediately after injection and up to 72 hours post-injection, before and immediately after injection and up to 72 hours post-injection|Temperature needed at the injection site to homogenize at the point of injection, Measurement of thermal image of the injection point before and immediately after injection and up to 72 hours post-injection, Before and immediately after injection and up to 72 hours post-injection
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