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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02747823




Registration number
NCT02747823
Ethics application status
Date submitted
19/04/2016
Date registered
22/04/2016

Titles & IDs
Public title
PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)
Scientific title
A Randomized, Double-blind, Single-dose, 3-way, Parallel Group, Comparator-controlled, Adaptive Design, Pharmacokinetic, Safety, and Tolerability Study in Healthy Male Volunteers to Evaluate Bioequivalence of CBT124 to Avastin® (EU and US)
Secondary ID [1] 0 0
ACTRN12616000428460
Secondary ID [2] 0 0
CBT124/NHV/001
Universal Trial Number (UTN)
Trial acronym
CBT124NHV001
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CBT124
Treatment: Other - EU Sourced Avastin®
Treatment: Other - US Sourced Avastin®

Experimental: CBT124 - CBT124, single dose of 1 mg/kg, IV infusion

Active comparator: EU Sourced Avastin® - EU Sourced Avastin®, single dose of 1 mg/kg, IV infusion

Active comparator: US Sourced Avastin® - US Sourced Avastin®, single dose of 1 mg/kg, IV infusion


Treatment: Other: CBT124
1 mg/kg IV infusion

Treatment: Other: EU Sourced Avastin®
1 mg/kg IV infusion

Treatment: Other: US Sourced Avastin®
1 mg/kg IV infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration-time curve of the analyte in plasma
Timepoint [1] 0 0
from 0 (baseline) up to 95 days extrapolated infinity (AUC(0 - 8))
Secondary outcome [1] 0 0
Area under the concentration-time curve
Timepoint [1] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [2] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [2] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [3] 0 0
Time to maximum observed concentration (tmax)
Timepoint [3] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [4] 0 0
Terminal half-life (t½)
Timepoint [4] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [5] 0 0
Terminal rate constant (?z)
Timepoint [5] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [6] 0 0
Systemic clearance (CL)
Timepoint [6] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [7] 0 0
Volume of distribution at steady state (Vss)
Timepoint [7] 0 0
from time 0 to the last quantifiable data point (AUC0-t)
Secondary outcome [8] 0 0
Immunogenicity will be assessed by the incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (nAb)
Timepoint [8] 0 0
Day 1 through last volunteer last visit
Secondary outcome [9] 0 0
Safety and tolerability will be assessed by clinical laboratory tests, vital signs, 12-lead ECGs, physical examinations, assessment of adverse events (AE), injection site reactions and concomitant medications
Timepoint [9] 0 0
Day 1 through last volunteer last visit

Eligibility
Key inclusion criteria
1. Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight = 60kg and = 100 kg (inclusive)
2. Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG at screening and admission
3. Subjects whose clinical laboratory test results are normal, or where outside the reference range is judged as not clinically relevant by the Investigator
4. Have systolic blood pressure = 140 and = 90 mmHg
5. Have physical examination results without clinically relevant findings at screening and admission
6. Have 12-lead ECG results without clinically relevant findings at screening and admission
7. Subjects who are non-smokers and have not regularly used tobacco or nicotine containing products
8. Males must be willing to use a medically acceptable method of contraception from the time of the administration of investigational product (IP), throughout the study
9. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
10. Must be able to provide informed consent which must be obtained prior to any study related procedures
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have a history of hypersensitivity or allergic reactions
2. Have a history of or presence of current clinically significant gastrointestinal disorder
3. Have a history of and/or current cardiac disease
4. Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening
5. Have a history of cancer
6. Have an illness within 30 days prior to screening, or prior to dosing, that is classed as clinically significant by the Investigator
7. Prior exposure to any investigational monoclonal antibody
8. Any clinically significant infection, in the opinion of the Investigator, ongoing at screening or admission to the clinical unit
9. Have had major surgery
10. Have received live vaccine(s)
11. Have an intake of alcoholic beverages
12. Have reasonable evidence of drug abuse as indicated by a positive urinary drug test at screening or admission
13. Have taken medication
14. Have donated > 100 mL blood within 4 weeks prior to the administration of the study drug
15. Have participated in another clinical study of an investigational drug
16. Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason
17. Impaired liver function as determined by: Serum alanine aminotransferase and/or aspartate aminotransferase > 1.5 x upper limit of normal (ULN) at screening or admission. Subjects with values between ULN and 1.5 x ULN may be included in the study if considered not clinically significant by the Investigator

Study design
Purpose of the study
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 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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cipla BioTec Pvt. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Schwabe, MD(GenSur)
Address 0 0
Auckland Clinical studies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Renuka Joshi, BAMS, MD
Address 0 0
Country 0 0
Phone 0 0
+91 8698082266
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As sponsors, we would be protecting the confidentiality of the subjects and would be unaware of the IPD ourselves.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02747823