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Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator

NCT03131700 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-04-12

No results posted yet for this study

Summary

The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.

Conditions

  • Healthy

Interventions

BIOLOGICAL

RPH001

Avastin® has been approved for treatment of various cancers in many countries of the world including the USA, EU countries, and Turkey. In Turkey, Avastin® is approved with a different trade name, Altuzan®, for treatment of metastatic colorectal cancer.

BIOLOGICAL

Avastin®

R-Pharm created a biological analog of Avastin®, RPH-001. RPH-001 and Avastin® have similar physicochemical properties, pharmacokinetic profile and affinity to human vascular endothelial growth factor, similar toxicity and efficacy confirmed by preclinical study results.

Sponsors & Collaborators

  • TRPHARM

    lead INDUSTRY

Principal Investigators

  • Zafer Sezer, PHD · IKUM

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2018-01-31
Completion
2018-01-31

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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 NCT03131700 on ClinicalTrials.gov