A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: BC106 insulin lispro
- Registration Number
- NCT01638325
- Lead Sponsor
- Adocia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BC106 Insulin Lispro BC106 insulin lispro 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. Insulin Lispro Insulin Lispro 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇸🇬Singapore, Singapore