NCT02660502

An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects. Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits. The total trial maximum duration for a subject will be up to 10 weeks.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Biochaperone insulin lispro 0.1 U/kg	Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
DRUG	Biochaperone insulin lispro 0.2 U/kg	Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
DRUG	Biochaperone insulin lispro 0.4 U/kg	Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
DRUG	Humalog®	Injection of a single dose of Humalog® at the dose of 0.2 U/kg

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-01-21
• Last updated: 2016-05-30

Locations

1 site across 1 country: Germany