To hear about similar clinical trials, please enter your email below
Trial Title:
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
NCT ID:
NCT05738993
Condition:
Breast Cancer
Conditions: Official terms:
Pertuzumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
BCD-178
Description:
A single intravenous (IV) infusion at a dose of 420 mg
Arm group label:
BCD-178 group
Other name:
pertuzumab
Intervention type:
Drug
Intervention name:
Perjeta
Description:
A single intravenous (IV) infusion at a dose of 420 mg
Arm group label:
Perjeta Group
Other name:
pertuzumab
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
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City Polyclinic №77
Address:
City:
Saint Petersburg
Zip:
192177
Country:
Russian Federation
Facility:
Name:
X7 Clinical Research
Address:
City:
Saint Petersburg
Zip:
194214
Country:
Russian Federation
Start date:
August 8, 2022
Completion date:
January 31, 2024
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738993
