Non-Small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: RPH-001
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: bevacizumab biosimilar
Current Sponsor code: RPH-001
Other descriptive name: BEVACIZUMAB BIOSIMILA
Sponsors
TRPHARM
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: I-1. Healthy male subjects aged 18 to 55 years inclusive. I-2. 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). I-3. Certified as healthy by a comprehensive clinical assessment (detailed medical history [hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 3 weeks prior start of the trial, registration of life style and habits such as consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse]) and complete physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Lymph nodes, skin, and neurological/psychiatric). I-4. Normal vital signs after 10 minutes resting in supine position: • 90 mmHg =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: E-1. 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. E-2. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month). E-3. Blood or plasma donation, or transfusion with any volume, within 3 months before inclusion. E-4. Symptomatic hypotension, irrespective of the decrease in blood pressure. E-5. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. E-6. Major surgery including appendectomy with in last 12 weeks. E-7. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day). E-8. Current smoker of more than 5 cigarettes or equivalent per day during the study and unable to completely stop smoking during the hospitalization. E-9. Excessive consumption of beverages containing xanthine bases such as tea, coffee, coke etc. (more than 500 mg xanthine per day). E-10. Medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months. E-11. Any medication (including St John’s Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. E-12. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. E-13. Any subject in the exclusion period of a previous study according to applicable regulations. E-14. Any subject who cannot be contacted in case of emergency. E-15. Any subject who is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study. E-16. 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). E-17. Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). E-18. Positive alcohol test at screening or baseline visits E-19. Any contraindications to biological molecules according to the applicable labeling. E-20. Vegetarian diet E-21. Participation in another clinical trial at same time or within the preceding 3 months (calculated from the date of the final examination of the previous study), except for previous BE trials in which case 8 weeks are sufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare pharmacokinetic profile of RPH-001 (TRPHARM) versus EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.;Secondary Objective: To assess safety (including immunogenicity) and tolerability of test and reference products.;Primary end point(s): Primary Pharmacokinetic Endpoints: Cmax, AUC(o-t), and AUC(0-8). ;Timepoint(s) of evaluation of this end point: 100 days after the administration of IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Pharmacokinetic Endpoints: tmax, t1/2, ?z, CL, Vss Safety Endpoints: Physical examinations, laboratory tests, vital signs, electrocardiogram (ECG) evaluations, adverse events (AEs) and serious adverse events (SAEs). ;Timepoint(s) of evaluation of this end point: 100 days after the administration of IMP | — |
Countries
Turkey
Contacts
Public ContactMEDICAL MANAGER
MONITOR CRO
Outcome results
None listed