None listed
Conditions
Brief summary
This study is a randomised controlled trial to evaluate the safety and pharmacokinetics of a single intravenous dose of the new drug GB221, compared to the drug Herceptin (also known as trastuzumab, Registered Trademark) in healthy volunteers. Who is it for? This trial is open to males aged between 18 and 45 years of age, with additional details listed in the Inclusion Criteria section of this form. The trial has been designed to look at how safe and well-tolerated GB221 is when administered to humans intravenously as compared to Herceptin Registered Trademark. The study will also look at how quickly GB221 is absorbed into the blood, how much of it is absorbed and how long it takes to body to remove it (this is known as the study of pharmacokinetics) when compared to Herceptin (Registered Trademark). You will be randomised to one of two intervention arms, where in one arm you will receive a dose of the new investigational drug being tested, GB221, administered as a single IV injection (8mg/kg) over 90 minutes. In the other arm, you will receive Herceptin (trastuzumab) at a dose of 8mg/kg administered as an IV infusion over 90 minutes. 10 weeks following this intervention, you will be assessed on various safety outcomes to determine the usefulness of the drug.
Interventions
Single dose of study drug GB221 administered as a single IV injection (8mg/kg) over 90 minutes.
Sponsors
Genor Biopharma
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males aged 18 to 45 years. 2. Healthy as judged by medical examination and medical history, and clinical chemistry and haematology 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 study-related procedures being conducted
Exclusion criteria
1. 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. 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.
Outcome results
None listed