PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US) (CBT124NHV001)

Cipla

Status and phase

Unknown

Phase 1

Conditions

Healthy

Treatments

Biological: CBT124

Biological: US Sourced Avastin®

Biological: EU Sourced Avastin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02747823

CBT124/NHV/001

ACTRN12616000428460 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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