A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adocia
• Collaborator: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

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