Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects
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
1 other identifier
interventional
128
1 country
1
Brief Summary
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2017
CompletedJuly 30, 2018
July 1, 2018
1.2 years
January 20, 2017
July 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
area under curve (AUC)0~∞
4 months
Study Arms (3)
BAT1706
EXPERIMENTALBAT1706 injection
EU-sourced Avastin
ACTIVE COMPARATOREU-sourced Avastin
US-sourced Avastin
ACTIVE COMPARATORUS-sourced Avastin
Interventions
Eligibility Criteria
You may qualify if:
- Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
- Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 ECG.
- Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinical relevant.
You may not qualify if:
- 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.
- 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.
- Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
- Intake of herbal remedies within 14 days prior to study drug administration.
- History of alcohol abuse or a positive alcohol test on screening or admission to the clinical center.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christchurch Clinical Studies Trust Ltd (CCST)
Christchurch, 8011, New Zealand
Related Publications (1)
Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin(R)) in Healthy Male Subjects. BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7.
PMID: 31016568DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Wynne, Medical Doc
Director
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 25, 2017
Study Start
March 15, 2016
Primary Completion
May 16, 2017
Study Completion
June 28, 2017
Last Updated
July 30, 2018
Record last verified: 2018-07