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Status unknownNCT02747823CBT124NHV001Updated Sep 19, 2016

PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)

A Phase 1 interventional study of CBT124 and EU Sourced Avastin® in Healthy, sponsored by Cipla BioTec Pvt. Ltd.. Status unknown at 1 site in New Zealand. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-19.

Sponsored by Cipla BioTec Pvt. Ltd. · Phase 1 and Interventional

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the detailed description

Cipla BioTec, a pharmaceutical company (company developing drugs), is developing its own formulation of bevacizumab called CBT124 which is similar to Avastin(Registered Trademark). The formulation is, intended for intravenous (into a vein) administration for the treatment of certain cancers. CBT124 is also a type of monoclonal antibody with a proposed biological activity similar to bevacizumab. Research on CBT124 indicates that it should act the same as Avastin(Registered Trademark) in the body. It is expected that CBT124 will provide all the clinical advantages of the marketed drug Avastin(Registered Trademark). The main purpose of this study is to test that whether CBT124 behaves the same in the human body as Avastin(Registered Trademark) i.e. produce the same amount/concentration of drug in the blood as the EU and USA marketed drug, Avastin(Registered Trademark). This is called a 'biosimilar' study. 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 (body's defense system) response) of the 3 drugs when given intravenously (into a vein) to healthy male participants: new drug called CBT124, marketed drug Avastin(Registered Trademark) approved in United States (US), marketed drug Avastin(Registered Trademark) approved in European Union (EU). The results will be compared to see if these drugs behave the same and are therefore equivalent. In order to measure this, blood samples will be collected after treatment has been given and the amount of drug in the blood measured at specific times. In addition, the study will also compare and analyse the effect the drug has on your immune system from blood samples. Safety and tolerability of both drugs will also be monitored and compared.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Cipla BioTec Pvt. Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    CBT124

    CBT124, single dose of 1 mg/kg, IV infusion

    Biological: CBT124

  • Active comparator
    EU Sourced Avastin®

    EU Sourced Avastin®, single dose of 1 mg/kg, IV infusion

    Biological: EU Sourced Avastin®

  • Active comparator
    US Sourced Avastin®

    US Sourced Avastin®, single dose of 1 mg/kg, IV infusion

    Biological: US Sourced Avastin®

Interventions

  • BiologicalCBT124

    1 mg/kg IV infusion

  • BiologicalEU Sourced Avastin®

    1 mg/kg IV infusion

  • BiologicalUS Sourced Avastin®

    1 mg/kg IV infusion

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma

    Time frame: from 0 (baseline) up to 95 days extrapolated infinity (AUC(0 - ∞))

Secondary outcomes

  1. Area under the concentration-time curve

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  2. Maximum observed plasma concentration (Cmax)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  3. Time to maximum observed concentration (tmax)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  4. Terminal half-life (t½)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  5. Terminal rate constant (λz)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  6. Systemic clearance (CL)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  7. Volume of distribution at steady state (Vss)

    Time frame: from time 0 to the last quantifiable data point (AUC0-t)

  8. 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

  9. 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

07

Study locations

1 of 1 sites recruiting
  • Auckland Clinical Studies Ltd., 3 Ferncroft Street, Grafton, Auckland
    Auckland, 1150, New Zealand
    • Christian Schwabe, MS · Contact · christian@clinicalstudies.co.nz · +6493733474
    • Sepehr Shakib · Principal investigator
    • Chris Wynne · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — As sponsors, we would be protecting the confidentiality of the subjects and would be unaware of the IPD ourselves.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02747823
Lead sponsor
Cipla BioTec Pvt. Ltd.
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Apr 22, 2016
Start date
Jun 2016
Primary completion
Oct 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Sep 19, 2016

Study contacts

Renuka Joshi, BAMS, MD
Contact
renuka.joshi@ciplabiotec.com
+91 8698082266
Renuka Joshi, BAMS, MD
Contact
renuka.joshi@ciplabiotec.com
+918698082266
Christian Schwabe, MD(GenSur)
principal investigator · Auckland Clinical studies
Sepehr Shakib, MBBS,FRACP
principal investigator · c/o CMAX - a division of IDT Australia Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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