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Trial registered on ANZCTR


Registration number
ACTRN12611001171909
Ethics application status
Approved
Date submitted
8/11/2011
Date registered
9/11/2011
Date last updated
9/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blind, parallel group, comparative Phase I study to evaluate the safety and pharmacokinetics of a single intravenous dose of GB221 compared to Herceptin Registered Trademark (trastuzumab) in healthy volunteers.
Scientific title
A randomised, double blind, parallel group, comparative Phase I study to evaluate the safety and pharmacokinetics of a single intravenous dose of GB221 compared to Herceptin Registered Trademark (trastuzumab) in healthy volunteers.
Secondary ID [1] 273280 0
NIL
Secondary ID [2] 273291 0
NIL
Universal Trial Number (UTN)
U1111-1125-5193
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety and Pharmokinetics of new study drug GB221 279129 0
Condition category
Condition code
Cancer 279231 279231 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of study drug GB221 administered as a single IV injection (8mg/kg) over 90 minutes.
Intervention code [1] 283637 0
Treatment: Drugs
Comparator / control treatment
Herceptin (trastuzumab) 8mg/kg administered as an IV infusion over 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 279870 0
Safety of study drug will be measured as follows:
- Physical Examination
- Vital Signs
- Laboratory Parameters
- 12-lead ECG
- Echocardiogram
Timepoint [1] 279870 0
10 weeks
Secondary outcome [1] 294646 0
Pharmacokinetics of study drug.

A maximum of 20 timepoints within the 10-week study period will be analysed. Blood samples for the determination of serum concentrations of GB221 will be collected from patients.
Timepoint [1] 294646 0
10 weeks.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following screening, subjects who meet the inclusion/exclusion criteria are to be randomly assigned to receive either GB221 or Herceptin Registered Trademark (1:1 ratio). There will be 16 subjects in each treatment group. Both site staff and subjects will be blinded as to which treatment they are to receive. Pharmacy staff will be responsible for assigning subjects to treatment groups as per the randomisation list provided by Genor Biopharma Co. Ltd. Randomisation will be via a master randomisation list produced by Trident Clinical Research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a master randomisation list produced by INC Research.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase I, pharmacokinetics study.
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284116 0
Commercial sector/Industry
Name [1] 284116 0
Genor Biopharma
Address [1] 284116 0
1011 Ha Lei Road
Suite 101
Zhangjiang, Pudong
Shanghai 201203
Country [1] 284116 0
China
Primary sponsor type
Commercial sector/Industry
Name
Genor Biopharma
Address
1011 Ha Lei Road
Suite 101
Zhangjiang, Pudong
Shanghai 201203
Country
China
Secondary sponsor category [1] 269076 0
None
Name [1] 269076 0
Address [1] 269076 0
Country [1] 269076 0
Other collaborator category [1] 252319 0
Commercial sector/Industry
Name [1] 252319 0
INC Research
Address [1] 252319 0
124 Lipson Street
PORT ADELAIDE SA 5015
Country [1] 252319 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272119 0
Bellberry Ltd
Ethics committee address [1] 272119 0
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 272119 0
Australia
Date submitted for ethics approval [1] 272119 0
21/09/2011
Approval date [1] 272119 0
28/10/2011
Ethics approval number [1] 272119 0
2011-09-450

Summary
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.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 33319 0
Address 33319 0
Country 33319 0
Phone 33319 0
Fax 33319 0
Email 33319 0
Contact person for public queries
Name 16566 0
Alex Seta
Address 16566 0
INC Research
Level 1, 20 Atherton Road
Oakleigh VIC 3166 Australia
Country 16566 0
Australia
Phone 16566 0
+61 (0) 3 9567 7600
Fax 16566 0
+61 (0) 3 9775 3370
Email 16566 0
aseta@incresearch.com
Contact person for scientific queries
Name 7494 0
David Fuller
Address 7494 0
INC Research
Suite 204, 27 Merriwa St
Gordon NSW 2072
Country 7494 0
Australia
Phone 7494 0
+61 (0)2 9499 9996
Fax 7494 0
+61 (0)2 9499 9998
Email 7494 0
dfuller@incresearch.com

No data has been provided for results reporting
Summary results
Not applicable