NCT04235439

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

A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Lispro Injection With Both EU - Approved and US - Licensed Humalog® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Gan & Lee Insulin Lispro Injection	All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.

Timeline

• Start date: 2019-04-23
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2020-01-21
• Last updated: 2020-02-13

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study