A first-in-human Phase 1 study was completed Q4 2019 to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of AB101. In the study, AB101 was administered in three sequential ascending cohorts to subjects with type 1 diabetes mellitus who remained on background subcutaneous insulin.

AB101 was generally safe and well tolerated, without dose-limiting side effects or occurrence of sudden insulin release. At the mid- and high-dosing cohorts, administration of AB101 resulted in a slow onset and sustained increase in insulin levels, and a dose-dependent insulin time-action profile for more than seven days. Decreased background basal insulin requirements were observed generally, and increased glucose requirements were seen during periodic hyperinsulinemic-euglycemic clamp tests, which are used to evaluate insulin pharmacology. These effects correlated with the observed concentration-time profile of AB101.

However, at the higher doses, the necessary drug volume was greater than anticipated, as was variability in the pharmacokinetic absorption profile between patients. Consequently, the Company believes that additional formulation development is required before advancing the program further in the clinic. If interested in learning more about the program, please contact