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

NCT03131700 | Withdrawn Phase 1 DMC

• 1 other identifier: RPH001BEV01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

RPH101; RPH-101; Biosimilar; Bevacizumab; Safety

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration

  Cmax

  Until 100 days after administration

• Area under concentration-time curve from time zero to the last sampling time

  Area Under the Curve - AUC(0-t)

  Until 100 days after administration

• Area under concentration-time curve from time zero to infinity

  Area Under the Curve - AUC(0-∞)

  Until 100 days after administration

Secondary Outcomes (18)

• Concentration-time profiles

  Until 100 days after administration

• Time to maximum concentration (Tmax)

  Until 100 days after administration

• Terminal elimination half-life (t½)

  Until 100 days after administration

• Terminal elimination rate constant (λz)

  Until 100 days after administration

• Apparent volume of distribution (Vz)

  Until 100 days after administration

Study Arms (2)

RPH-001

EXPERIMENTAL

A single dose of RPH-001 will be administered (IV) 5 mg/kg dose .

Biological: RPH001

EU sourced Avastin®

ACTIVE COMPARATOR

A single dose of Avastin® will be administered (IV) 5 mg/kg dose .

Biological: Avastin®

Interventions

RPH001 BIOLOGICAL

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.

RPH-001

Avastin® BIOLOGICAL

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.

Also known as: Bevacizumab

EU sourced Avastin®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 18 to 55 years inclusive.
• Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight ≥ 60 kg and ≤ 100 kg (inclusive).

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• Positive alcohol test at screening or baseline visits

Sponsors & Collaborators

• TRPHARM: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zafer Sezer, PHD

  IKUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 27, 2017
• Study Start: December 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2017-09