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

NCT02747823 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-09-19

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CBT124

1 mg/kg IV infusion

BIOLOGICAL

EU Sourced Avastin®

1 mg/kg IV infusion

BIOLOGICAL

US Sourced Avastin®

1 mg/kg IV infusion

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Cipla BioTec Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Christian Schwabe, MD(GenSur) · Auckland Clinical studies

  • Sepehr Shakib, MBBS,FRACP · c/o CMAX - a division of IDT Australia Ltd.

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02747823 on ClinicalTrials.gov