Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®

May 3, 2020 updated by: Biocad

A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers

A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation
        • Limited Liability Company Research Center Eco-Bezopasnost (OOO Research Center Eco-Bezopasnost)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Signed ICF for participation in the study
  2. Men from 18 to 45 years old (inclusive) at the time of signing the ICF
  3. BMI within the normal limits (18.0 to 30 kg/m2)
  4. The subject is able to follow the Protocol procedures (in the investigator's opinion)
  5. The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests
  6. Normal hemodynamic parameters: systolic BP from 90 mmHg to 130 mmHg; diastolic BP from 60 mmHg to 90 mmHg; HR from 60 bpm to 90 bpm
  7. The subject and his sex partner of childbearing potential consent to implement reliable contraceptive methods from the moment the subject signs the ICF and until the subject completes the study. This requirement does not apply to those subjects who had undergone surgical sterilization. Reliable contraception methods mean one barrier method in combination with one of the following: spermicides, intrauterine device and/or oral contraceptives used by the subject's partner.

  8. The subject agrees not to drink alcohol for 24 h prior to the infusion of the test/reference drug and for the entire period while the subject is in the study.

    -

Exclusion Criteria:

  1. Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol
  2. Acute infections within 4 weeks before signing the ICF
  3. Results of laboratory and/or instrumental tests are outside the site's normal range
  4. Any surgery done within 30 days before the screening or planned within 30 days after the subject completes the study
  5. Impossibility to insert an intravenous catheter for blood collection (e.g., because of a skin condition at the venipuncture site)
  6. A history of allergies
  7. Known hypersensitivity to any component of BCD-148 or Soliris®, murine proteins or other drug components; hypersensitivity to any component of the meningococcal vaccine
  8. The subject had used any medications that significantly affect hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before signing the ICF and/or the subject needs any medications (other than the study drugs) to be taken during the entire study period
  9. The subject had previously used eculizumab and/or other therapeutic monoclonal antibodies against complement C5
  10. Regular use (oral or parenteral) of any drugs, including OTC products, vitamins or biologically active supplements within 14 calendar days before signing the ICF
  11. A history of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to signing the ICF
  12. Acute or chronic infections or other diseases that, in the investigator's opinion, may affect the PK, PD or safety of the study products
  13. HIV, HCV, HBV infection, syphilis.
  14. Meningococcal infection in the past (documented or mentioned verbally by the subject)
  15. Vaccination within 4 weeks before the planned infusion date, except for vaccination against Neisseria meningitidis given to all subjects in the screening period
  16. The subject refuses to get a vaccination against Neisseria meningitidis during the screening period .
  17. The subject smokes more than 10 cigarettes per day
  18. The subject consumes more than 10 units of alcohol per week (1 unit equals to 0.5 L of beer, 200 mL of wine or 50 mL of a strong alcohol beverage) or has a history of alcohol, recreational drug or medication abuse, or tests positive for alcohol and/or psychoactive substances during the screening examination
  19. Donation of ≥ 450 mL of blood or plasma within 60 calendar days before signing the ICF.

  20. Participation in any drug clinical studies within 30 calendar days prior to signing the informed consent form and through the entire period of study participation.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BCD-148
39 healthy subjects received BCD-148, 900 mg, a single drip infusion over 25-45 min
Biological: BCD-148
single intravenous infusion of BCD-148 (900 mg)
Other Names:
  • eculizumab
ACTIVE_COMPARATOR: Soliris
39 healthy subjects received Soliris, 900 mg, a single drip infusion over 25-45 min
Biological: Soliris
single intravenous infusion of Soliris (900 mg)
Other Names:
  • eculizumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC0-∞ of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
AUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)
from 0 to 1392 hours post-infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Cmax of eculizumab (maximum concentration of eculizumab in the serum)
from 0 to 1392 hours post-infusion
Тmax of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Тmax of eculizumab (time to Cmax)
from 0 to 1392 hours post-infusion
AUC0-1392 of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
AUC0-1392 of eculizumab (the area under the Concentration vs. Time curve from 0 to 1392 h post-infusion)
from 0 to 1392 hours post-infusion
Т1/2 of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Т1/2 of eculizumab (half-life)
from 0 to 1392 hours post-infusion
Vd of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Vd of eculizumab (steady-state volume of distribution)
from 0 to 1392 hours post-infusion
Кel of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Кel of eculizumab (elimination constant)
from 0 to 1392 hours post-infusion
Cl of Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
Cl of eculizumab (clearance)
from 0 to 1392 hours post-infusion
ABEC(0-1392) CH50
Time Frame: from 0 to 1392 hours post-infusion
ABEC(0-1392) CH50 (the area between the baseline and effect curves for hemolytic activity of serum complement from 0 to 1392 h)
from 0 to 1392 hours post-infusion
AUEC(0-1392) CH50
Time Frame: from 0 to 1392 hours post-infusion
AUEC(0-1392) CH50 ((area under the Time vs. Effect curve from 0 to 1392 h)
from 0 to 1392 hours post-infusion
Emin CH50
Time Frame: from 0 to 1392 hours post-infusion
Emin CH50 (minimum hemolytic complement activity from 0 to 1392 h)
from 0 to 1392 hours post-infusion
Tmin CH50
Time Frame: from 0 to 1392 hours post-infusion
Tmin CH50 (time to minimum hemolytic complement activity within the period from 0 to 1392 h)
from 0 to 1392 hours post-infusion
Subjects With AEs/SAEs Related to Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
The percentage of subjects with AEs/SAEs that, in the investigator's opinion, are related to eculizumab
from 0 to 1392 hours post-infusion
Subjects Who Develop Grade 3/4 AEs Related to Eculizumab
Time Frame: from 0 to 1392 hours post-infusion
• The percentage of subjects with СТСАЕ v. 4.03 grade 3/4 AEs that, in the investigator's opinion, are related to eculizumab, by study arms.
from 0 to 1392 hours post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-148-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings