An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BioChaperone insulin lispro 0.1 U/kg
|
Drug: Biochaperone insulin lispro 0.1 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
|
| Experimental: BioChaperone insulin lispro 0.2 U/kg
|
Drug: Biochaperone insulin lispro 0.2 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
|
| Experimental: BioChaperone insulin lispro 0.4 U/kg
|
Drug: Biochaperone insulin lispro 0.4 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
|
| Active Comparator: Humalog®
|
Drug: Humalog®
Injection of a single dose of Humalog® at the dose of 0.2 U/kg
|
Outcome Measures
Primary Outcome Measures
- AUCLispro(0-30min) [Up to 30 minutes]
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
Secondary Outcome Measures
- AUCGIR(0-last) [Up to 8 hours]
Area under the glucose infusion rate time curve from 0 hours until the end of clamp
- Adverse Events [Up to 10 weeks]
Number of adverse events
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Profil Institut für Stoffwechselforschung GmbH | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Adocia
- Eli Lilly and Company
Investigators
- Principal Investigator: Grit Andersen, MD, Profil GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC3-CT017