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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adocia
• Collaborator: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

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.