Status:
UNKNOWN
PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)
Lead Sponsor:
Cipla BioTec Pvt. Ltd.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 A...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02747823
Start Date
June 1 2016
End Date
December 1 2016
Last Update
September 19 2016
Active Locations (1)
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1
Auckland Clinical Studies Ltd., 3 Ferncroft Street, Grafton, Auckland
Auckland, Auckland, New Zealand, 1150