Clinical Trial of Comparative Study of GB221 Pharmacokinetics

Inclusion criteria

To be enrolled in the study, subjects must meet the following criteria

• Males aged 18 to 45 years.
• Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
• Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
• Normal or non-clinically significant ECG.
• Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
• Willingness to give written and informed consent prior to any studyrelated procedures being conducted

Exclusion criteria

Subjects will be ineligible for the study if any of the following criteria apply:

• Receipt of any investigational agent or drug within 4 weeks of entry to the study.
• Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
• Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
• Clinically significant drug allergy or sensitivity to any medication.
• A history of chronic or recurrent infections.
• A recent history of surgery.
• History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
• Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
• A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
• A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
• Vaccination of any type within the previous month.
• A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
• Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
• Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
• History of asthma or other chronic respiratory disease in the past 5 years.
• History of neurological or neuromuscular disease.
• History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
• History of bladder or urethral disease.
• Smoking cigarettes > 10 per day.
• Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.