Clinical Trial of Comparative Study of GB221 Pharmacokinetics

Launched by GENOR BIOPHARMA CO., LTD. · Nov 21, 2019

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • To be enrolled in the study, subjects must meet the following criteria
• • 1. Males aged 18 to 45 years.
• • 2. Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
• • 3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
• • 4. Normal or non-clinically significant ECG.
• • 5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
• • 6. 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:
• • 1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.
• • 2. 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.
• • 3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
• • 4. Clinically significant drug allergy or sensitivity to any medication.
• • 5. A history of chronic or recurrent infections.
• • 6. A recent history of surgery.
• • 7. History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
• • 8. Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
• • 9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
• • 10. A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
• • 11. Vaccination of any type within the previous month.
• • 12. 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.
• • 13. Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
• • 14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
• • 15. History of asthma or other chronic respiratory disease in the past 5 years.
• • 16. History of neurological or neuromuscular disease.
• • 17. History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
• • 18. History of bladder or urethral disease.
• • 19. Smoking cigarettes \> 10 per day.
• • 20. Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.

Trial Officials