PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

Phase 1 Completed 36 enrolled Gan and Lee Pharmaceuticals, USA

RandomizedCrossoverDouble-blindTreatment

Summary

Primary objective: To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan \& Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects Secondary objectives: To compare the PK and PD parameters of the three insulin lispro preparations To evaluate the single dose safety and local tolerability of the three insulin lispro preparations

Timeline

Start: 2019-04-23
Primary completion: 2019-07-03
Completion: 2019-07-03

Outcome

Met primary endpoint

paper Bioequivalence to both EU- and US-reference products were shown for all three GL insulins. PMID 37735841 ↗

paper both 90% and 95% confidence intervals were within 80%-125% in all three studies. PMID 37735841 ↗

Publications

Chen W, Lu J, Plum-Morschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin(R)), lispro (prandilin(R)) and glargine (basalin(R)) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Lispro	Protein / enzyme biologic	0.2 iu/kg	Subcutaneous