drugset / Trial / NCT02660502
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2016-05
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.1 iu/kg | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.2 iu/kg | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.4 iu/kg | — |
Indications
No indication recorded.