Healthy MenPhase 1NCT05825781
Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man
A Phase 1 study testing Pertuzumab and Perjeta® in people with Healthy Men, run by Mabscale, LLC at 1 site in Russia.
Trial summary
PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men. 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
- Healthy Men
- What is being tested?
- Pertuzumab and Perjeta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jul 2023to Sep 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
- Healthy Volunteers, Men, 18 to 45 years old.
- Body mass index 18,5 - 30,0 kg/m2.
- Availability of written informed consent of the volunteer to participate in the study in accordance with applicable law.
- Volunteers should behave adequately, coherent speech should be observed.
- Volunteer consent to use an adequate method of contraception (barrier methods of contraception in combination with one of the following: non-hormonal intrauterine device; condom with intravaginal spermicide; cervical caps with spermicide; diaphragm with spermicide in the sexual partner) during the entire period of participation in the study and at least 6 months after the use of the study drug/comparator drug.
- The verified diagnosis is "healthy": the absence of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular and bronchopulmonary systems, central nervous system (preliminary standard clinical, laboratory and instrumental studies did not reveal the presence of any diseases).
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- Negative blood tests for HIV, syphilis and hepatitis (HBsAg and anti-HCV).
- LVEF ≥ 60% according to ECHO-CG.
- Negative urine test for drug and drug abuse.
- Negative breath alcohol test.
Who cannot join
- Aggravated allergic anamnesis.
- Hypersensitivity to pertuzumab and / or other substances that are part of the study drug.
- Any vaccination up to 30 days before the expected date of administration of the drug according to medical history.
- Drug intolerance.
- Known intolerance to monoclonal antibody drugs (mouse, chimeric, humanized, human) according to medical history.
- The results of laboratory analyzes provided for by the protocol are outside the established normative indicators of the investigator site.
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- Oncological diseases according to medical history.
- Acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, mental illness.
- More than 4 episodes of respiratory infections in the last 6 months prior to screening.
- Surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
- Acute infectious diseases less than 4 weeks prior to study entry.
- Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before the start of this study.
- Regular drug intake less than 2 weeks before the start of the study.
- Systolic blood pressure less than 100 mm Hg. Art. or above 130 mm Hg. Art.; diastolic blood pressure less than 60 mm Hg. Art. or above 90 mm Hg. Art.; Heart rate less than 60 bpm or more than 90 bpm; respiratory rate less than 12 and more than 20 per minute
- Donation of blood (450 ml of blood or more) less than 3 months before the start of the study.
- Participation in clinical drug trials less than 3 months before the start of this study.
- Taking more than 10 units of alcohol per week (where each unit is equal to 50 ml of strong alcoholic beverages or 500 ml of beer) or anamnestic information about alcoholism, drug addiction, drug abuse.
- Smoking more than 10 cigarettes a day.
- Any reason that, in the opinion of the investigator, would prevent a volunteer from participating in the study.
- Mental, physical and other reasons that do not allow the subject adequately assess his behavior and correctly fulfill the conditions of the research protocol.
- Special diet (eg vegetarian, vegan) or lifestyle (including night work and extreme physical activity such as heavy lifting) that may interfere with the study.
- Volunteers who are expected to have problems with placing venous catheters or performing veinpuncture.
- Depression according to medical history.
- Insomnia according to medical history.
- Inability to follow the schedule of study visits by a volunteer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Comparative Clinical Study Evaluating Pharmacokinetics and Safety in Single Intravenous Use of Pertuzumab (Manufactured by Mabscale, LLC) Compared to Perjeta® in Healthy Men
PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men. The purpose of the study is to demonstrate equivalence of pharmacokinetics, immunogenicity and safety of Pertuzumab (manufactured by Mabscale, LLC) to Perjeta®.
Read the detailed description
Pertuzumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Perjeta®, which is approved as treatment in patients with metastatic breast cancer in combination with trastuzumab and docetaxel and in patients with non-metastatic breast cancer in combination with trastuzumab and chemotherapy. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
- Conditions
- Healthy Men
- Being tested
- Pertuzumab, Perjeta®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
i.v.
Perjeta®Drug
i.v.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab (manufactured by Mabscale, LLC) | Experimental | Eligible subjects (57 healthy men) will receive once Pertuzumab 420 mg/14 ml in 250 ml 0,9 % NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits. Receives: Drug: Pertuzumab |
| Perjeta® | Active comparator | Eligible subjects (57 healthy men) will receive once Perjeta® 420 mg/14 ml in 250 ml 0,9% NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits. Receives: Drug: Perjeta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of pertuzumab in serum of subjects
Measured: Baseline up to 100 days after study drug administration
Secondary outcomes (1)
Rate of subjects with antibodies against pertuzumab in serum
Measured: Baseline up to 100 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 Jul 2023
- Primary completion22 Jan 2024
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabscale, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825781
- Sponsor's protocol ID
- PERT-1/12102020
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Comparative Clinical Study Evaluating Pharmacokinetics and Safety in Single Intravenous Use of Pertuzumab (Manufactured by Mabscale, LLC) Compared to Perjeta® in Healthy Men
- ClinicalTrials.gov ID
- NCT05825781
- Acronym / sponsor ID
- PERT-1/12102020
- Conditions
- Healthy Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mabscale, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Apr 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.
PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men. The purpose of the study is to demonstrate equivalence of pharmacokinetics, immunogenicity and safety of Pertuzumab (manufactured by Mabscale, LLC) to Perjeta®.
Detailed description
Pertuzumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Perjeta®, which is approved as treatment in patients with metastatic breast cancer in combination with trastuzumab and docetaxel and in patients with non-metastatic breast cancer in combination with trastuzumab and chemotherapy. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab (manufactured by Mabscale, LLC) | Experimental | Drug: PertuzumabEligible subjects (57 healthy men) will receive once Pertuzumab 420 mg/14 ml in 250 ml 0,9 % NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits. |
| Perjeta® | Active comparator | Drug: Perjeta®Eligible subjects (57 healthy men) will receive once Perjeta® 420 mg/14 ml in 250 ml 0,9% NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy Volunteers, Men, 18 to 45 years old.
- Body mass index 18,5 - 30,0 kg/m2.
- Availability of written informed consent of the volunteer to participate in the study in accordance with applicable law.
- Volunteers should behave adequately, coherent speech should be observed.
- Volunteer consent to use an adequate method of contraception (barrier methods of contraception in combination with one of the following: non-hormonal intrauterine device; condom with intravaginal spermicide; cervical caps with spermicide; diaphragm with spermicide in the sexual partner) during the entire period of participation in the study and at least 6 months after the use of the study drug/comparator drug.
Key exclusion criteria (25 listed)
- Aggravated allergic anamnesis.
- Hypersensitivity to pertuzumab and / or other substances that are part of the study drug.
- Any vaccination up to 30 days before the expected date of administration of the drug according to medical history.
- Drug intolerance.
- Known intolerance to monoclonal antibody drugs (mouse, chimeric, humanized, human) according to medical history.
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 |
|---|---|---|
| Pertuzumabi.v. | Drug | Pertuzumab (manufactured by Mabscale, LLC) |
| Perjeta®i.v. | Drug | Perjeta® |
Primary outcome
Concentration of pertuzumab in serum of subjects
Time frame: Baseline up to 100 days after study drug administration
1 secondary outcome
Rate of subjects with antibodies against pertuzumab in serum
Time frame: Baseline up to 100 days after study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pertuzumab and Perjeta® in people with Healthy Men, run by Mabscale, LLC at 1 site 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 10 inclusion and 25 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Concentration of pertuzumab in serum of subjects (time frame: Baseline up to 100 days after study drug administration). 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 16 Aug 2024.