Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Biochaperone insulin lispro 0.1 U/kg · 1 trial · 1 indication
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
| Arm | Type | Description |
|---|---|---|
| BioChaperone insulin lispro 0.1 U/kg | EXPERIMENTAL | - |
| BioChaperone insulin lispro 0.2 U/kg | EXPERIMENTAL | - |
| BioChaperone insulin lispro 0.4 U/kg | EXPERIMENTAL | - |
| Humalog® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Biochaperone insulin lispro 0.1 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg |
| Biochaperone insulin lispro 0.2 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg |
| Biochaperone insulin lispro 0.4 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg |
| Humalog® | DRUG | Injection of a single dose of Humalog® at the dose of 0.2 U/kg |
Inclusion Criteria: * Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * BMI between 18.5 and 25.0 kg∙m-2, both inclusive. * Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL). * Signed and dat...
Biochaperone insulin lispro 0.1 U/kg is an investigational insulin lispro formulation being developed by Eli Lilly and Company. It is a small molecule therapeutic candidate studied in a Phase 1 clinical trial. The 0.1 U/kg refers to the dose administered in that trial, which evaluated the pharmacokinetics of a single dose in healthy Japanese subjects.
Biochaperone insulin lispro 0.1 U/kg is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 trial conducted for this investigational insulin lispro formulation.
Biochaperone insulin lispro 0.1 U/kg is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials for this asset are currently active.
Biochaperone insulin lispro 0.1 U/kg has been studied in one completed Phase 1 trial, NCT02660502. Titled an euglycemic clamp trial to evaluate pharmacokinetics of single doses of BioChaperone insulin lispro in healthy Japanese subjects, it enrolled 15 participants in Germany. The trial was randomized, double-blind, and active-controlled, and it has completed.
The trial for Biochaperone insulin lispro 0.1 U/kg, NCT02660502, was a Phase 1 euglycemic clamp study in healthy Japanese subjects. It enrolled 15 participants, used a randomized, double-blind, active-controlled design, and was conducted in Germany. Participants were 20 years of age or older, and the study has been completed.