An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects. Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits. The total trial maximum duration for a subject will be up to 10 weeks.

Official Title
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A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Biochaperone insulin lispro 0.1 U/kg
* Drug: Biochaperone insulin lispro 0.2 U/kg
* Drug: Biochaperone insulin lispro 0.4 U/kg
* Drug: Humalog®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator. BMI between 18.5 and 25.0 kg∙m-2, both inclusive. Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL). Signed and dated informed consent obtained before any trial-related activities. Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products. Receipt of any investigational medicinal product within 3 months before randomisation in this trial. Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioChaperone insulin lispro 0.1 U/kg<br> | Drug: Biochaperone insulin lispro 0.1 U/kg<br>* Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg<br>|
| Experimental: BioChaperone insulin lispro 0.2 U/kg<br> | Drug: Biochaperone insulin lispro 0.2 U/kg<br>* Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg<br>|
| Experimental: BioChaperone insulin lispro 0.4 U/kg<br> | Drug: Biochaperone insulin lispro 0.4 U/kg<br>* Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg<br>|
| Active Comparator: Humalog®<br> | Drug: Humalog®<br>* Injection of a single dose of Humalog® at the dose of 0.2 U/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCLispro(0-30min) | Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes | Up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCGIR(0-last) | Area under the glucose infusion rate time curve from 0 hours until the end of clamp | Up to 8 hours | 
| Adverse Events | Number of adverse events | Up to 10 weeks |