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

NCT02747823 | Unknown Phase 1 DMC

• 2 other identifiers: CBT124/NHV/001ACTRN12616000428460
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve of the analyte in plasma

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

Secondary Outcomes (9)

• Area under the concentration-time curve

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

• Maximum observed plasma concentration (Cmax)

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

• Time to maximum observed concentration (tmax)

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

• Terminal half-life (t½)

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

• Terminal rate constant (λz)

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

Study Arms (3)

CBT124

EXPERIMENTAL

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

Biological: CBT124

EU Sourced Avastin®

ACTIVE COMPARATOR

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

Biological: EU Sourced Avastin®

US Sourced Avastin®

ACTIVE COMPARATOR

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

Biological: US Sourced Avastin®

Interventions

CBT124 BIOLOGICAL

1 mg/kg IV infusion

CBT124

EU Sourced Avastin® BIOLOGICAL

1 mg/kg IV infusion

EU Sourced Avastin®

US Sourced Avastin® BIOLOGICAL

1 mg/kg IV infusion

US Sourced Avastin®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cipla BioTec Pvt. Ltd.: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

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

Auckland, Auckland, 1150, New Zealand

RECRUITING

Study Officials

• Christian Schwabe, MD(GenSur)

  Auckland Clinical studies

  PRINCIPAL INVESTIGATOR

• Sepehr Shakib, MBBS,FRACP

  c/o CMAX - a division of IDT Australia Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renuka Joshi, BAMS, MD

CONTACT

+91 8698082266; renuka.joshi@ciplabiotec.com

Renuka Joshi, BAMS, MD

CONTACT

+918698082266; renuka.joshi@ciplabiotec.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 22, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)