Clinical trial · Interventional
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
NCT05738993CI-TRIAL-00064139unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCD-178 | Drug | Pertuzumab | ALIAS |
| Perjeta | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BCD-178 group
- description
- single IV infusion of BCD-178 at a dose of 420 mg
- interventionNames
- Drug: BCD-178
- type
- ACTIVE_COMPARATOR
- label
- Perjeta Group
- description
- single IV infusion of Perjeta at a dose of 420 mg
- interventionNames
- Drug: Perjeta
Primary outcomes (1)
- measure
- AUC0-∞
- timeFrame
- pre-dose to day 91, 23 timepoints
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.