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Healthy SubjectsPhase 1NCT04027803

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

A Phase 1 study testing BCD-148 and Soliris in people with Healthy Subjects, run by Biocad at 1 site 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

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 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 Subjects
What is being tested?
BCD-148 and Soliris
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteRussia
Study dates
21 Sep 2018to 7 Apr 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 ICF for participation in the study
  • Men from 18 to 45 years old (inclusive) at the time of signing the ICF
  • BMI within the normal limits (18.0 to 30 kg/m2)
  • The subject is able to follow the Protocol procedures (in the investigator's opinion)
  • The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests
  • 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
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  • 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.
  • 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.
  • -

Who cannot join

  • Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol
  • Acute infections within 4 weeks before signing the ICF
  • Results of laboratory and/or instrumental tests are outside the site's normal range
  • Any surgery done within 30 days before the screening or planned within 30 days after the subject completes the study
  • Impossibility to insert an intravenous catheter for blood collection (e.g., because of a skin condition at the venipuncture site)
  • A history of allergies
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  • Known hypersensitivity to any component of BCD-148 or Soliris®, murine proteins or other drug components; hypersensitivity to any component of the meningococcal vaccine
  • 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
  • The subject had previously used eculizumab and/or other therapeutic monoclonal antibodies against complement C5
  • Regular use (oral or parenteral) of any drugs, including OTC products, vitamins or biologically active supplements within 14 calendar days before signing the ICF
  • A history of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to signing the ICF
  • Acute or chronic infections or other diseases that, in the investigator's opinion, may affect the PK, PD or safety of the study products
  • HIV, HCV, HBV infection, syphilis.
  • Meningococcal infection in the past (documented or mentioned verbally by the subject)
  • Vaccination within 4 weeks before the planned infusion date, except for vaccination against Neisseria meningitidis given to all subjects in the screening period
  • The subject refuses to get a vaccination against Neisseria meningitidis during the screening period .
  • The subject smokes more than 10 cigarettes per day
  • 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
  • Donation of ≥ 450 mL of blood or plasma within 60 calendar days before signing the ICF.
  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Limited Liability Company Research Center Eco-Bezopasnost (OOO Research Center Eco-Bezopasnost)

    Saint Petersburg

Other trials in Russia

About this study

Official title: 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

Being tested
BCD-148, Soliris

What participants receive

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

  • BCD-148Biological

    Also called eculizumab

    single intravenous infusion of BCD-148 (900 mg)

  • SolirisBiological

    Also called eculizumab

    single intravenous infusion of Soliris (900 mg)

Study groups in NCT04027803
Study groupRoleWhat they receive
BCD-148Experimental39 healthy subjects received BCD-148, 900 mg, a single drip infusion over 25-45 min
Receives: Biological: BCD-148
SolirisActive comparator39 healthy subjects received Soliris, 900 mg, a single drip infusion over 25-45 min
Receives: Biological: Soliris

What is being measured

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

  1. AUC0-∞ of Eculizumab

    AUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)

    Measured: from 0 to 1392 hours post-infusion

Secondary outcomes (13)

  1. Cmax of Eculizumab

    Cmax of eculizumab (maximum concentration of eculizumab in the serum)

    Measured: from 0 to 1392 hours post-infusion

  2. Тmax of Eculizumab

    Тmax of eculizumab (time to Cmax)

    Measured: from 0 to 1392 hours post-infusion

  3. AUC0-1392 of Eculizumab

    AUC0-1392 of eculizumab (the area under the Concentration vs. Time curve from 0 to 1392 h post-infusion)

    Measured: from 0 to 1392 hours post-infusion

  4. Т1/2 of Eculizumab

    Т1/2 of eculizumab (half-life)

    Measured: from 0 to 1392 hours post-infusion

  5. Vd of Eculizumab

    Vd of eculizumab (steady-state volume of distribution)

    Measured: from 0 to 1392 hours post-infusion

  6. Кel of Eculizumab

    Кel of eculizumab (elimination constant)

    Measured: from 0 to 1392 hours post-infusion

  7. Cl of Eculizumab

    Cl of eculizumab (clearance)

    Measured: from 0 to 1392 hours post-infusion

  8. ABEC(0-1392) CH50

    ABEC(0-1392) CH50 (the area between the baseline and effect curves for hemolytic activity of serum complement from 0 to 1392 h)

    Measured: from 0 to 1392 hours post-infusion

  9. AUEC(0-1392) CH50

    AUEC(0-1392) CH50 ((area under the Time vs. Effect curve from 0 to 1392 h)

    Measured: from 0 to 1392 hours post-infusion

  10. Emin CH50

    Emin CH50 (minimum hemolytic complement activity from 0 to 1392 h)

    Measured: from 0 to 1392 hours post-infusion

  11. Tmin CH50

    Tmin CH50 (time to minimum hemolytic complement activity within the period from 0 to 1392 h)

    Measured: from 0 to 1392 hours post-infusion

  12. Subjects With AEs/SAEs Related to Eculizumab

    The percentage of subjects with AEs/SAEs that, in the investigator's opinion, are related to eculizumab

    Measured: from 0 to 1392 hours post-infusion

  13. Subjects Who Develop Grade 3/4 AEs Related to Eculizumab

    • 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.

    Measured: from 0 to 1392 hours post-infusion

Timeline

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

  1. First posted22 Jul 2019
  2. Study start21 Sep 2018
  3. Primary completion7 Apr 2019
  4. Study completion7 Apr 2019

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04027803
Sponsor's protocol ID
BCD-148-3
Status last verified
May 2020
First submitted
16 Jul 2019
Last updated
15 May 2020
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-148 and Soliris in people with Healthy Subjects, run by Biocad 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 9 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 15 May 2020. 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?

Yes. Results are posted in the registry (first posted 15 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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-∞ of Eculizumab (time frame: from 0 to 1392 hours post-infusion). 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 NCT04027803.

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 15 May 2020.

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