- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747823
PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US) (CBT124NHV001)
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Renuka Joshi, BAMS, MD
- Phone Number: +91 8698082266
- Email: renuka.joshi@ciplabiotec.com
Study Contact Backup
- Name: Renuka Joshi, BAMS, MD
- Phone Number: +918698082266
- Email: renuka.joshi@ciplabiotec.com
Study Locations
-
-
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Auckland, New Zealand, 1150
- Recruiting
- Auckland Clinical Studies Ltd., 3 Ferncroft Street, Grafton, Auckland
-
Contact:
- Christian Schwabe, MS
- Phone Number: +6493733474
- Email: christian@clinicalstudies.co.nz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight ≥ 60kg and ≤ 100 kg (inclusive)
- Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG at screening and admission
- Subjects whose clinical laboratory test results are normal, or where outside the reference range is judged as not clinically relevant by the Investigator
- Have systolic blood pressure ≤ 140 and ≥ 90 mmHg
- Have physical examination results without clinically relevant findings at screening and admission
- Have 12-lead ECG results without clinically relevant findings at screening and admission
- Subjects who are non-smokers and have not regularly used tobacco or nicotine containing products
- 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
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
- Must be able to provide informed consent which must be obtained prior to any study related procedures
Exclusion Criteria:
- Have a history of hypersensitivity or allergic reactions
- Have a history of or presence of current clinically significant gastrointestinal disorder
- Have a history of and/or current cardiac disease
- Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening
- Have a history of cancer
- Have an illness within 30 days prior to screening, or prior to dosing, that is classed as clinically significant by the Investigator
- Prior exposure to any investigational monoclonal antibody
- Any clinically significant infection, in the opinion of the Investigator, ongoing at screening or admission to the clinical unit
- Have had major surgery
- Have received live vaccine(s)
- Have an intake of alcoholic beverages
- Have reasonable evidence of drug abuse as indicated by a positive urinary drug test at screening or admission
- Have taken medication
- Have donated > 100 mL blood within 4 weeks prior to the administration of the study drug
- Have participated in another clinical study of an investigational drug
- Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason
- 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 Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CBT124
CBT124, single dose of 1 mg/kg, IV infusion
|
1 mg/kg IV infusion
|
ACTIVE_COMPARATOR: EU Sourced Avastin®
EU Sourced Avastin®, single dose of 1 mg/kg, IV infusion
|
1 mg/kg IV infusion
|
ACTIVE_COMPARATOR: US Sourced Avastin®
US Sourced Avastin®, single dose of 1 mg/kg, IV infusion
|
1 mg/kg IV infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma
Time Frame: from 0 (baseline) up to 95 days extrapolated infinity (AUC(0 - ∞))
|
from 0 (baseline) up to 95 days extrapolated infinity (AUC(0 - ∞))
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Maximum observed plasma concentration (Cmax)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Time to maximum observed concentration (tmax)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Terminal half-life (t½)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Terminal rate constant (λz)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Systemic clearance (CL)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Volume of distribution at steady state (Vss)
Time Frame: from time 0 to the last quantifiable data point (AUC0-t)
|
from time 0 to the last quantifiable data point (AUC0-t)
|
Immunogenicity will be assessed by the incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (nAb)
Time Frame: Day 1 through last volunteer last visit
|
Day 1 through last volunteer last visit
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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
Time Frame: Day 1 through last volunteer last visit
|
Day 1 through last volunteer last visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Schwabe, MD(GenSur), Auckland Clinical Studies
- Principal Investigator: Sepehr Shakib, MBBS,FRACP, c/o CMAX - a division of IDT Australia Ltd.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT124/NHV/001
- ACTRN12616000428460 (REGISTRY: ANZCTR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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