Breast Cancer
Conditions
Brief summary
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers
Interventions
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent; * Men aged 18-45 years; * Body mass index (BMI) in the range of 18.5 30.0 kg/m2; * The confirmed healthy status; * Left ventricular ejection fraction (LVEF) \> 50 % based on the results of EchoCG at screening; * Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;
Exclusion criteria
* Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs; * Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site; * History or evidence of any chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ | pre-dose to day 91, 23 timepoints | Area under the concentration-time curve of the drug over the time interval from zero to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | pre-dose to day 91, 23 timepoints | time from administration to maximum observed plasma concentration of the drug |
| T½ | pre-dose to day 91, 23 timepoints | Elimination half-life |
| Kel | pre-dose to day 91, 23 timepoints | elimination rate constant |
| Cmax | pre-dose to day 91, 23 timepoints | maximum observed plasma concentration of the drug |
| Vd | pre-dose to day 91, 23 timepoints | volume of distribution |
| safety assessment | Day 1 to day 91 | frequency, severity, and profile of adverse events |
| immunogenicity assessment | pre-dose to day 91, 5 timepoints | binding anti-drug antibodies (BAb) and neutralizing anti-drug antibodies (NAb) |
| CL | pre-dose to day 91, 23 timepoints | total clearance |
Countries
Russia
Outcome results
None listed