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出境医 / 临床实验 / Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Study Description
Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Subjects | Biological: BCD-148 Biological: Soliris | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 21, 2018 |
| Actual Primary Completion Date : | April 7, 2019 |
| Actual Study Completion Date : | April 7, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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 Name: eculizumab
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Active Comparator: Soliris
39 healthy subjects received Soliris, 900 mg, a single drip infusion over 25-45 min
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Biological: Soliris
single intravenous infusion of Soliris (900 mg)
Other Name: eculizumab
|
Outcome Measures
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- Cmax of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Cmax of eculizumab (maximum concentration of eculizumab in the serum)
- Тmax of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Тmax of eculizumab (time to Cmax)
- 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)
- Т1/2 of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Т1/2 of eculizumab (half-life)
- Vd of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Vd of eculizumab (steady-state volume of distribution)
- Кel of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Кel of eculizumab (elimination constant)
- Cl of Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ]Cl of eculizumab (clearance)
- 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)
- 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)
- Emin CH50 [ Time Frame: from 0 to 1392 hours post-infusion ]Emin CH50 (minimum hemolytic complement activity from 0 to 1392 h)
- 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)
- 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
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- 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.
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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.
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Exclusion Criteria:
- 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
- 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.
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Contacts and Locations
Locations
| Russian Federation | |
| Limited Liability Company Research Center Eco-Bezopasnost (OOO Research Center Eco-Bezopasnost) | |
| Saint Petersburg, Russian Federation | |
Sponsors and Collaborators
Biocad
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 16, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Results First Submitted Date ICMJE | January 13, 2020 | ||||
| Results First Posted Date ICMJE | May 15, 2020 | ||||
| Last Update Posted Date | May 15, 2020 | ||||
| Actual Study Start Date ICMJE | September 21, 2018 | ||||
| Actual Primary Completion Date | April 7, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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 | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy Subjects | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
78 | ||||
| Original Actual Enrollment ICMJE |
39 | ||||
| Actual Study Completion Date ICMJE | April 7, 2019 | ||||
| Actual Primary Completion Date | April 7, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Russian Federation | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027803 | ||||
| Other Study ID Numbers ICMJE | BCD-148-3 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Biocad | ||||
| Study Sponsor ICMJE | Biocad | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Biocad | ||||
| Verification Date | May 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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