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HealthyPhase 1CBT124NHV001NCT02747823

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

A Phase 1 study testing CBT124, EU Sourced Avastin® and US Sourced Avastin® in people with Healthy, run by Cipla BioTec Pvt. Ltd. at 1 site in New Zealand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
CBT124, EU Sourced Avastin® and US Sourced Avastin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteNew Zealand
Study dates
Jun 2016to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Renuka Joshi, BAMS, MD contact

+91 8698082266

renuka.joshi@ciplabiotec.com

Renuka Joshi, BAMS, MD contact

+918698082266

renuka.joshi@ciplabiotec.com

New Zealand1 site, 1 recruiting

  • Auckland Clinical Studies Ltd., 3 Ferncroft Street, Grafton, Auckland

    Auckland, Auckland, 1150

    Christian Schwabe, MS, +6493733474, christian@clinicalstudies.co.nz

    Sepehr Shakib

    Recruiting

Other trials in New Zealand

About this study

Official 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)

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.

Conditions
Healthy
Being tested
CBT124, EU Sourced Avastin®, US Sourced Avastin®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT124Biological

    1 mg/kg IV infusion

  • EU Sourced Avastin®Biological

    1 mg/kg IV infusion

  • US Sourced Avastin®Biological

    1 mg/kg IV infusion

Study groups in NCT02747823
Study groupRoleWhat they receive
CBT124ExperimentalCBT124, single dose of 1 mg/kg, IV infusion
Receives: Biological: CBT124
EU Sourced Avastin®Active comparatorEU Sourced Avastin®, single dose of 1 mg/kg, IV infusion
Receives: Biological: EU Sourced Avastin®
US Sourced Avastin®Active comparatorUS Sourced Avastin®, single dose of 1 mg/kg, IV infusion
Receives: Biological: US Sourced Avastin®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (9)

  1. Area under the concentration-time curve

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

  2. Maximum observed plasma concentration (Cmax)

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

  3. Time to maximum observed concentration (tmax)

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

  4. Terminal half-life (t½)

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

  5. Terminal rate constant (λz)

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

  6. Systemic clearance (CL)

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

  7. Volume of distribution at steady state (Vss)

    Measured: 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)

    Measured: 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

    Measured: Day 1 through last volunteer last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747823
Sponsor's protocol ID
CBT124/NHV/001
Other IDs
ACTRN12616000428460
Acronym
CBT124NHV001
Status last verified
Jul 2016
First submitted
19 Apr 2016
Last updated
19 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: As sponsors, we would be protecting the confidentiality of the subjects and would be unaware of the IPD ourselves.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBT124, EU Sourced Avastin® and US Sourced Avastin® in people with Healthy, run by Cipla BioTec Pvt. Ltd. at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Renuka Joshi, BAMS, MD (+91 8698082266, renuka.joshi@ciplabiotec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve of the analyte in plasma (time frame: from 0 (baseline) up to 95 days extrapolated infinity (AUC(0 - ∞))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.

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