Breast CancerPhase 1NCT05738993
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
A Phase 1 study testing BCD-178 and Perjeta in people with Breast Cancer, run by Biocad at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BCD-178 and Perjeta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesRussia
- Study dates
- 8 Aug 2022to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
City Polyclinic №77
Saint Petersburg, 192177
X7 Clinical Research
Saint Petersburg, 194214
About this study
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
- Breast Cancer
- Being tested
- BCD-178, Perjeta
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-178Drug
Also called pertuzumab
A single intravenous (IV) infusion at a dose of 420 mg
PerjetaDrug
Also called pertuzumab
A single intravenous (IV) infusion at a dose of 420 mg
| Study group | Role | What they receive |
|---|---|---|
| BCD-178 group | Experimental | single IV infusion of BCD-178 at a dose of 420 mg Receives: Drug: BCD-178 |
| Perjeta Group | Active comparator | single IV infusion of Perjeta at a dose of 420 mg Receives: Drug: Perjeta |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Area under the concentration-time curve of the drug over the time interval from zero to infinity
Measured: pre-dose to day 91, 23 timepoints
Secondary outcomes (8)
Cmax
maximum observed plasma concentration of the drug
Measured: pre-dose to day 91, 23 timepoints
Tmax
time from administration to maximum observed plasma concentration of the drug
Measured: pre-dose to day 91, 23 timepoints
T½
Elimination half-life
Measured: pre-dose to day 91, 23 timepoints
Kel
elimination rate constant
Measured: pre-dose to day 91, 23 timepoints
CL
total clearance
Measured: pre-dose to day 91, 23 timepoints
Vd
volume of distribution
Measured: pre-dose to day 91, 23 timepoints
safety assessment
frequency, severity, and profile of adverse events
Measured: Day 1 to day 91
immunogenicity assessment
binding anti-drug antibodies (BAb) and neutralizing anti-drug antibodies (NAb)
Measured: pre-dose to day 91, 5 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start8 Aug 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738993
- Sponsor's protocol ID
- BCD-178-1
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05738993
- Acronym / sponsor ID
- BCD-178-1
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-178 group | Experimental | Drug: BCD-178single IV infusion of BCD-178 at a dose of 420 mg |
| Perjeta Group | Active comparator | Drug: Perjetasingle IV infusion of Perjeta at a dose of 420 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-178Also: pertuzumabA single intravenous (IV) infusion at a dose of 420 mg | Drug | BCD-178 group |
| PerjetaAlso: pertuzumabA single intravenous (IV) infusion at a dose of 420 mg | Drug | Perjeta Group |
Primary outcome
AUC0-∞
Time frame: pre-dose to day 91, 23 timepoints
Area under the concentration-time curve of the drug over the time interval from zero to infinity
8 secondary outcomes
Cmax
Time frame: pre-dose to day 91, 23 timepoints
Tmax
Time frame: pre-dose to day 91, 23 timepoints
T½
Time frame: pre-dose to day 91, 23 timepoints
Kel
Time frame: pre-dose to day 91, 23 timepoints
CL
Time frame: pre-dose to day 91, 23 timepoints
Vd
Time frame: pre-dose to day 91, 23 timepoints
safety assessment
Time frame: Day 1 to day 91
immunogenicity assessment
Time frame: pre-dose to day 91, 5 timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-178 and Perjeta in people with Breast Cancer, run by Biocad at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: pre-dose to day 91, 23 timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.