Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator
Phase 1
Withdrawn
- Conditions
- Healthy
- Registration Number
- NCT03131700
- Lead Sponsor
- TRPHARM
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Area under concentration-time curve from time zero to the last sampling time Until 100 days after administration Area Under the Curve - AUC(0-t)
Area under concentration-time curve from time zero to infinity Until 100 days after administration Area Under the Curve - AUC(0-∞)
Maximum plasma concentration Until 100 days after administration Cmax
- Secondary Outcome Measures
Name Time Method Blood Pressure Until 100 days after administration Physical examination Until 100 days after administration Concentration-time profiles Until 100 days after administration RPH-001 and Avastin®
Terminal elimination rate constant (λz) Until 100 days after administration RPH-001 and Avastin®
Nature, frequency, severity and relationship to study drug of recorded adverse events Until 100 days after administration Heart rate Until 100 days after administration Body temperature Until 100 days after administration Neutralizing antibody (NAb) Until 100 days after administration Terminal elimination half-life (t½) Until 100 days after administration RPH-001 and Avastin®
Volume of distribution at steady state (Vss) Until 100 days after administration Respiratory rate Until 100 days after administration Time to maximum concentration (Tmax) Until 100 days after administration RPH-001 and Avastin®
ECG Until 100 days after administration Anti-drug-antibody (ADA) Until 100 days after administration Apparent volume of distribution (Vz) Until 100 days after administration RPH-001 and Avastin®
Clearance (CL) Until 100 days after administration Oxygen saturation Until 100 days after administration Clinical laboratory tests Until 100 days after administration