A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

Study Overview
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Brief Summary
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BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.

Official Title
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A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Insulin Lispro
* Drug: BC106 insulin lispro


Participation Criteria
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Eligibility Criteria
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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 per liter (mmol/L) at screening Exclusion Criteria: Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans Have a history of first-degree relatives known to have diabetes mellitus Have used systemic glucocorticoids within 3 months prior to entry into the study Have donated or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Lispro<br>15 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. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: BC106 Insulin Lispro<br>15 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. | Drug: BC106 insulin lispro<br>* Administered SC<br>* Other names: BioChaperone insulin lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |