A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

Adocia

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Insulin Lispro; Drug: BC106 insulin lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638325

H9D-MC-ITAG (Other Identifier)

14771

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Insulin Lispro

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin Lispro

BC106 Insulin Lispro

Experimental group

Description:

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.

Treatment:

Drug: BC106 insulin lispro