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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02747823
Ethics application status
Date submitted
19/04/2016
Date registered
22/04/2016
Date last updated
19/09/2016

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
Other interventions - CBT124
Other interventions - EU Sourced Avastin®
Other interventions - 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


Other interventions: CBT124
1 mg/kg IV infusion

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

Other interventions: US Sourced Avastin®
1 mg/kg IV infusion

Intervention code [1] 0 0
Other interventions
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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
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
This study aims to investigate the bioequivalence of new formulation of bevacizumab called
CBT124 and safety when compared to two already marketed formulations, one approved in US and
other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both
inclusive) can participate in this trial.

Participants will be randomised (allocated by chance) to either a test formulation or one of
the two marketed formulations of bevacizumab. Drugs will be administered intravenously once
only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of
drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and immunogenicity
(body's immune response) of the 3 drugs. In order to measure this, blood samples will be
collected at various points after treatment has been given.
Trial website
https://clinicaltrials.gov/show/NCT02747823
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
renuka.joshi@ciplabiotec.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02747823