A double‐blind, placebo‐controlled, single‐ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long‐acting glucagon analogue, in healthy subjects

To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long‐acting glucagon analogue under development, in healthy males and females presenting with no childbearing potential. A randomized, double‐blind, placebo‐controlled, single‐ascending dose study was conducted in 56 subjects who randomly received a single subcutaneous dose of HM15136 or its matching placebo at a ratio of 6:2 at 10, 20, 30, 50, 80, 100, and 120 μg/kg. All adverse events were mild and transient. Neither serious adverse events nor discontinuation as a result of adverse events occurred. The most frequent adverse drug reaction was nausea (5.3%, only in the 100‐ and 120‐μg/kg groups). HM15136, particularly at doses of 50 μg/kg or higher, increased fasting blood glucose, with a maximum increase and area under the curve of 1.5 mmol/L at day 10 (P = .006) and 166.3 day·mmol/L...