Clinical trial NCT03131700: Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: RPH101
RPH-101
Biosimilar
Bevacizumab
Safety
Lead sponsor: TRPHARM
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration
timeFrame: Until 100 days after administration
measure: Area under concentration-time curve from time zero to the last sampling time
timeFrame: Until 100 days after administration
measure: Area under concentration-time curve from time zero to infinity
timeFrame: Until 100 days after administration
Secondary outcomes:
measure: Concentration-time profiles
timeFrame: Until 100 days after administration
measure: Time to maximum concentration (Tmax)
timeFrame: Until 100 days after administration
measure: Terminal elimination half-life (t½)
timeFrame: Until 100 days after administration
measure: Terminal elimination rate constant (λz)
timeFrame: Until 100 days after administration
measure: Apparent volume of distribution (Vz)
timeFrame: Until 100 days after administration
measure: Clearance (CL)
timeFrame: Until 100 days after administration
measure: Volume of distribution at steady state (Vss)
timeFrame: Until 100 days after administration
measure: Nature, frequency, severity and relationship to study drug of recorded adverse events
timeFrame: Until 100 days after administration
measure: Physical examination
timeFrame: Until 100 days after administration
measure: Heart rate
timeFrame: Until 100 days after administration
measure: Blood Pressure
timeFrame: Until 100 days after administration
measure: Respiratory rate
timeFrame: Until 100 days after administration
measure: Oxygen saturation
timeFrame: Until 100 days after administration
measure: Body temperature
timeFrame: Until 100 days after administration
measure: ECG
timeFrame: Until 100 days after administration
measure: Clinical laboratory tests
timeFrame: Until 100 days after administration
measure: Anti-drug-antibody (ADA)
timeFrame: Until 100 days after administration
measure: Neutralizing antibody (NAb)
timeFrame: Until 100 days after administration
Other outcomes:
Locations:
Study officials:
affiliation: IKUM
name: Zafer Sezer, PHD
role: PRINCIPAL_INVESTIGATOR
References: