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BC106 insulin lispro

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

BC106 insulin lispro · 1 trial · 1 indication

Phase 1 1
NCT01638325A Study of Insulin Lispro With BioChaperone Excipient in Healthy ParticipantsHealthy Participants
COMPLETED37 Analytics
PHASE1COMPLETED
A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
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Study Endpoints

Primary Endpoints

Pharmacokinetics: Area under the concentration curve (AUC)
Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Maximum concentration (Cmax)
Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Time of maximum concentration (Tmax)
Baseline up to 8 hours post administration of study drug

Secondary Endpoints

Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro
Baseline up to 30 days
Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro
Baseline up to 30 days
Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro
Baseline up to 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Insulin LisproACTIVE_COMPARATOR15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
BC106 Insulin LisproEXPERIMENTAL15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.

Interventions

NameTypeDescription
Insulin LisproDRUGAdministered SC
BC106 insulin lisproDRUGAdministered SC
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are not of child-bearing potential * Have a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m\^2), inclusive * Are nonsmokers or have not smoked for at least 6 months prior to entering the study * Have a fasting plasma glucose less than 6.0 millimoles ...

Countries:Singapore
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Frequently asked questions about BC106 insulin lispro

What is BC106 insulin lispro used for?

BC106 insulin lispro is an investigational small molecule being studied in healthy participants. It is a formulation of insulin lispro combined with a BioChaperone excipient, intended for evaluation in a Phase 1 clinical trial. The study focuses on healthy volunteers to assess the product's effects.

Who makes BC106 insulin lispro?

BC106 insulin lispro is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting a Phase 1 clinical trial to evaluate this insulin lispro formulation with a BioChaperone excipient in healthy participants.

What phase is BC106 insulin lispro in?

BC106 insulin lispro is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 study has been completed, with results not yet publicly reported.

What clinical trials is BC106 insulin lispro in?

BC106 insulin lispro has one completed clinical trial, NCT01638325, titled "A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants." This Phase 1 study enrolled 37 participants in Singapore, was randomized and active-controlled, and included healthy volunteers aged 21 years and older.

Is BC106 insulin lispro the same as insulin lispro?

BC106 insulin lispro is a specific formulation of insulin lispro that includes a BioChaperone excipient. While it contains insulin lispro, the addition of the BioChaperone excipient distinguishes it as a separate investigational product being studied for its unique properties.