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

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2017

Primary Completion Date

January 31, 2018

Study Completion Date

January 31, 2018

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

Lead Sponsor

All Listed Sponsors
lead

TRPHARM

INDUSTRY

NCT03131700 - Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator | Biotech Hunter | Biotech Hunter