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HealthyPhase 1NCT05974969

A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects

A Phase 1 study testing BCD-264 and Darzalex in people with Healthy, run by Biocad at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects. 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
What is being tested?
BCD-264 and Darzalex
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
3 sitesRussia
Study dates
17 May 2023to 15 Aug 2023
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 to participate in the study.
  • Men aged 18-45 years inclusive at the time of signing the Informed Consent Form.
  • Body mass index (BMI) in the range of 18.5-30.0 kg/m2.
  • The confirmed "healthy" status based on the conventional clinical and laboratory assessments and investigations obtained as screening.
  • Hemodynamic parameters within the normal range: systolic blood pressure (SBP) in the range of 100-130 mmHg, diastolic (DBP) in the range of 60-90 mmHg, wrist pulse rate 60-90 bpm, obtained at screening.
  • The ability of the subject to follow the Protocol procedures, according to the Investigator.
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  • No history of alcoholism abuse or drug addiction and negative test results for alcohol, psychotropic and narcotic substances, psychoactive drugs at screening and before IP infusion.
  • The willingness of subjects, starting from the moment of signing the informed consent form, during the study and for 3 months after the IP administration, to use condoms during any sexual contact by penetration with persons of any sex, including pregnant women. This requirement does not apply to participants who underwent surgical sterilization (bilateral orchiectomy).
  • Willingness to refuse to donate sperm and to conceive a child starting from signing the informed consent form, during the study and for 3 months after the IP administration.
  • Willingness to refrain from drinking alcohol a day (24 hours) before the IP administration and for 96 hours after the administration, and then a day before each scheduled visit.
  • Willingness to refrain from smoking within 2 hours before the IP administration and then 2 hours before each measurement of blood pressure (BP), pulse rate at the wrist, respiratory rate, blood sampling, ECG.
  • Willingness to refrain from vaccination with live attenuated vaccines (intranasal influenza, measles, mumps, rubella, polio, BCG, yellow fever, chickenpox, and typhoid TY21a vaccines) during the main study period.
  • Willingness to refrain from taking any medications, including over-the-counter drugs, vitamins and food supplements, with the exception of drugs prescribed by the investigator for the treatment of AEs, throughout the study.
  • Willingness to refrain from donating blood and plasma for 6 months after the IP administration.

Who cannot join

  • Mental illness or other conditions that may affect the subject's ability to comply with the Study Protocol.
  • Any surgery performed less than 30 days before the screening.
  • Impossibility to insert a venous catheter for blood sampling (for example, due to skin disease at venipuncture sites).
  • History of severe hypersensitivity reactions (anaphylaxis or multiple drug allergy).
  • Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, and fully human) or any other components of the IP.
  • Administration and use of the following drugs:
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  • Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, within less than 14 calendar days prior to estimated date of randomization;
  • A history of receiving daratumumab and/or other anti-CD38 monoclonal antibodies.
  • Taking medications, including over-the-counter drugs that have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), within less than 30 days before the estimated date of randomization.
  • Taking drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) within less than 60 days before the estimated date of randomization.
  • Systemic use of antibacterial, antimycotic, antiviral or antiprotozoal drugs within less than 60 days before the estimated date of randomization.
  • Positive results of screening tests for HIV, hepatitis B and C viruses.
  • Positive result of indirect antiglobulin test (indirect Coombs test) at screening.
  • Conventional laboratory parameters or investigations out of the reference ranges accepted at the study sites.
  • Chronic diseases of the cardiovascular, bronchopulmonary, and neuroendocrine systems, as well as diseases of the gastrointestinal tract, kidneys, and blood.
  • Acute infectious diseases less than 4 weeks before the estimated date of randomization, as well as chronic and other diseases that, in the Investigator's opinion, may affect the PK parameters and safety of the IP.
  • Smoking over 10 cigarettes a day.
  • Consumption of more than 10 units of alcohol a week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 50 mL of spirits) or a history of alcoholism, drug addiction, or drug abuse.
  • Donation of ≥450 mL of blood or plasma within 60 calendar days prior to the expected date of randomization;
  • Participation in any clinical studies of medicinal products at the time of signing the informed consent or less than 30 calendar days before the expected date of randomization, if the subject received the medicinal product during the clinical study.
  • Previous participation in the same study if the subject was randomized and received the IP during the study.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • Institute of the Human Brain n. a. N.P. Bekhtereva Russian Academy of Sciences

    Saint Petersburg

  • Smorodintsev Research Institute of Influenza

    Saint Petersburg

  • X7 Clinical Research

    Saint Petersburg

Other trials in Russia

About this study

Official title: A Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Single Intravenous Infusion of BCD-264 and Darzalex® in Healthy Volunteers

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects.

Read the detailed description

In this clinical study, each subject will receive a single intravenous infusion of BCD-264 or Darzalex, depending on the group the subject will be randomized to. The drugs are administered at the study site at a dose of 8 mg/kg.

The subjects will be followed up and blood samples collected for pharmacokinetics, pharmacodynamics, immunogenicity and safety studies up to and including 71 study days after the administration of IP.

Conditions
Healthy
Being tested
BCD-264, Darzalex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-264Drug

    a single intravenous infusion of BCD-264

  • DarzalexDrug

    a single intravenous infusion of Darzalex

Study groups in NCT05974969
Study groupRoleWhat they receive
BCD-264ExperimentalINN: daratumumab, single IV infusion at a dose of 8 mg/kg.
Receives: Drug: BCD-264
DarzalexActive comparatorINN: daratumumab, single IV infusion at a dose of 8 mg/kg.
Receives: Drug: Darzalex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)

    Measured: Up to Day 71

Secondary outcomes (12)

  1. Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t)

    Measured: Up to Day 71

  2. Maximum observed drug concentration (Cmax)

    Measured: Up to Day 71

  3. Time from administration to maximum observed concentration of the drug (Тmax)

    Measured: Up to Day 71

  4. Elimination half-life (Т½)

    Measured: Up to Day 71

  5. Elimination rate constant (Кel)

    Measured: Up to Day 71

  6. Total clearance (Cl)

    Measured: Up to Day 71

  7. Volume of distribution (Vd)

    Measured: Up to Day 71

  8. Maximum effect (Emax)

    Pharmacodynamics will be evaluated based on the absolute count and percentage of CD38+ cells in peripheral blood (T cells, B cells, NK cells, plasmablasts and plasma cells)

    Measured: Up to Day 71

  9. Time to maximum effect (TEmax)

    Pharmacodynamics will be evaluated based on the absolute count and percentage of CD38+ cells in peripheral blood (T cells, B cells, NK cells, plasmablasts and plasma cells)

    Measured: Up to Day 71

  10. Incidence and characteristics of adverse events

    Measured: Up to Day 71

  11. Proportion of subjects with BAbs/NAbs

    Measured: Up to Day 71

  12. Time until the BAb/NAb development

    Measured: Up to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start17 May 2023
  3. Primary completion15 Aug 2023
  4. Study completion15 Aug 2023

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974969
Sponsor's protocol ID
BCD-264-1
Status last verified
Nov 2023
First submitted
28 Jun 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-264 and Darzalex in people with Healthy, run by Biocad at 3 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 14 inclusion and 21 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞) (time frame: Up to Day 71). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974969.

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 18 Nov 2023.

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