A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

Study Overview
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Brief Summary
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This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects. Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

Official Title
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A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female

Conditions
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Healthy

Intervention / Treatment
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* Drug: BioChaperone Lispro U-100
* Drug: BioChaperone Lispro U-200


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. Age ≥ 18 and ≤ 64 years, both inclusive. Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive. Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL). Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject). 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.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BioChaperone Lispro U-100<br>injection of 2 doses of 0.2 U/kg on separate visits | Drug: BioChaperone Lispro U-100<br>* Injection of BioChaperone Lispro U-100<br>|
| Experimental: BioChaperone Lispro U-200<br>injection of 2 doses of 0.2 U/kg on separate visits | Drug: BioChaperone Lispro U-200<br>* Injection of BioChaperone Lispro U-200<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCLisp (0-inf) | Area under the insulin lispro serum concentration - time curve from t=0 to infinity | 8 hours | 
| Cmax Lisp | Maximum observed insulin lispro serum concentration | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax Lisp | Time to maximum observed serum insulin lispro concentration | 8 hours | 
| AUCGIR(0-8h) | Area under the glucose infusion rate-time curve from t=0 to 8 hours | 8 hours | 
| GIRmax | Maximum glucose infusion rate | 8 hours | 
| tGIRmax | Time to maximum glucose infusion rate | 8 hours | 
| Number of Adverse events | Number of adverse events | Up to 9 weeks | 
| Local tolerability | Record of injection site reaction | Up to 9 weeks |