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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03030430
Registration number
NCT03030430
Ethics application status
Date submitted
20/01/2017
Date registered
25/01/2017
Date last updated
30/07/2018
Titles & IDs
Public title
Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects
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Scientific title
Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects
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Secondary ID [1]
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BAT-1706-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BAT1706 injection
Other interventions - EU-sourced Avastin
Other interventions - US-sourced Avastin
Experimental: BAT1706 - BAT1706 injection
Active Comparator: EU-sourced Avastin - EU-sourced Avastin
Active Comparator: US-sourced Avastin - US-sourced Avastin
Other interventions: BAT1706 injection
1mg/kg, IV on day 1
Other interventions: EU-sourced Avastin
1mg/kg, IV on day 1
Other interventions: US-sourced Avastin
1mg/kg, IV on day 1
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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area under curve (AUC)0~8
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Assessment method [1]
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Timepoint [1]
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4 months
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Eligibility
Key inclusion criteria
1. Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
2. Subjects who are healthy as determined by pre-study medical history, physical
examination, vital signs and 12 ECG.
3. Subjects whose clinical laboratory test results are normal, or where outside the
reference range are judged as not clinical relevant.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Have a history of and/or current clinically significant gastrointestinal, renal,
hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric
or allergic disease excluding mild asymptomatic seasonal allergies.
2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the
investigator.
3. History or current clinically significant, excluding mild asymptomatic seasonal
allergies, hypersensitivity or allergic reactions including known or suspected drug
hypersensitivity to any component of the study drug formulations or comparable drugs.
4. Any biological drug within 3 months or monoclonal antibodies within 9 months of study
drug administration.
5. Intake of herbal remedies within 14 days prior to study drug administration.
6. History of alcohol abuse or a positive alcohol test on screening or admission to the
clinical center.
7. Any persons who are:an employee of the Principal Investigator, clinical center,
Clinical Research Organization (CRO) or Sponsor;a relative of an employee of the
clinical center, the Investigators, CRO or the Sponsor.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/06/2017
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Sample size
Target
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Accrual to date
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Final
128
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bio-Thera Solutions
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and
comparators.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03030430
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Chris Wynne, Medical Doc
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Address
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Director
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03030430
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