A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01638325

Enrollment

Registered

2012-07-11

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGInsulin Lispro

Administered SC

DRUGBC106 insulin lispro

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026