Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
BAT-1706-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BAT1706 injection
Treatment: Other - EU-sourced Avastin
Treatment: Other - US-sourced Avastin

Experimental: BAT1706 - BAT1706 injection

Active comparator: EU-sourced Avastin - EU-sourced Avastin

Active comparator: US-sourced Avastin - US-sourced Avastin


Treatment: Other: BAT1706 injection
1mg/kg, IV on day 1

Treatment: Other: EU-sourced Avastin
1mg/kg, IV on day 1

Treatment: Other: US-sourced Avastin
1mg/kg, IV on day 1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
area under curve (AUC)0~8
Timepoint [1] 0 0
4 months

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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2017
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bio-Thera Solutions
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.
Trial website
https://clinicaltrials.gov/study/NCT03030430
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Chris Wynne, Medical Doc
Address 0 0
Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03030430