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

Healthy Clinical Trial

Official title:

Phase I, Double Blind, Randomized, Parallel-Arm, Single-Dose, Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (Avastin®, Roche) in Healthy Male Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03131700
• Other study ID #: RPH001BEV01
• Status: Withdrawn
• Phase: Phase 1
• First received: April 19, 2017
• Last updated: April 10, 2018
• Start date: December 2017
• Est. completion date: January 2018

Study information

• Verified date: September 2017
• Source: TRPHARM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TRPHARM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration	Cmax	Until 100 days after administration
Primary	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
Primary	Area under concentration-time curve from time zero to infinity	Area Under the Curve - AUC(0-8)	Until 100 days after administration
Secondary	Concentration-time profiles	RPH-001 and Avastin®	Until 100 days after administration
Secondary	Time to maximum concentration (Tmax)	RPH-001 and Avastin®	Until 100 days after administration
Secondary	Terminal elimination half-life (t½)	RPH-001 and Avastin®	Until 100 days after administration
Secondary	Terminal elimination rate constant (?z)	RPH-001 and Avastin®	Until 100 days after administration
Secondary	Apparent volume of distribution (Vz)	RPH-001 and Avastin®	Until 100 days after administration
Secondary	Clearance (CL)		Until 100 days after administration
Secondary	Volume of distribution at steady state (Vss)		Until 100 days after administration
Secondary	Nature, frequency, severity and relationship to study drug of recorded adverse events		Until 100 days after administration
Secondary	Physical examination		Until 100 days after administration
Secondary	Heart rate		Until 100 days after administration
Secondary	Blood Pressure		Until 100 days after administration
Secondary	Respiratory rate		Until 100 days after administration
Secondary	Oxygen saturation		Until 100 days after administration
Secondary	Body temperature		Until 100 days after administration
Secondary	ECG		Until 100 days after administration
Secondary	Clinical laboratory tests		Until 100 days after administration
Secondary	Anti-drug-antibody (ADA)		Until 100 days after administration
Secondary	Neutralizing antibody (NAb)		Until 100 days after administration