PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

Inclusion criteria

• Signed and dated informed consent obtained before any trial related activities. Trial related activities are any procedures that would not have been done during normal management of the subject
• Healthy male subjects
• Age between 18 and 64 years, both inclusive
• Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
• Fasting plasma glucose concentration <= 5.5 mmol/L (100 mg/dL) at screening
• Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator

Exclusion criteria

• Known or suspected hypersensitivity to IMP(s) or related product
• Previous participation in this trial. Participation is defined as randomized
• Receipt of any medicinal product in clinical development within 30 days before randomization in this trial
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
• Any history or presence of clinically relevant comorbidity, as judged by the Investigator
• Signs of acute illness as judged by the Investigator
• Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator
• Clinically significant abnormal screening laboratory tests, as judged by the Investigator
• Elevation of serum ALT> 10% above the ULN, or elevation of serum AST or serum bilirubin >20% above the ULN. (Note: Elevation of bilirubin is considered acceptable in case of Gilbert's disease and should be evaluated in clinical context)
• Elevation of serum creatinine > ULN, or elevation of serum urea > 10% above ULN
• Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
• Symptoms of arterial hypotension
• Heart rate at rest outside the range of 50-90 beats per minute
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator
• Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
• Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (on average)
• A positive result in the alcohol and/or urine drug screen at the screening visit
• Smoking more than 5 cigarettes or the equivalent per day
• Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
• Positive test for Hepatitis Bs antigen
• Positive test for Hepatitis C antibodies. (Presence of Hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative)
• Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
• Any medication (prescription and non-prescription drugs) within 7 days before IMP administration and/or anticoagulant therapy
• Blood donation or blood loss of more than 500mL within the last 3 months
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation

Explanatory note on Exclusion Criterion 24: With the exception of paracetamol or NSAIDs for occasional use to treat acute pain, as judged by the Investigator.