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

Biocad1 site in 1 country78 target enrollmentSeptember 21, 2018

ConditionsHealthy Subjects

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: Biocad
Enrollment: 78
Locations: 1
Primary Endpoint: AUC0-∞ of Eculizumab
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 21, 2018

End Date

April 7, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility 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.
•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

•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

Outcomes

Primary Outcomes

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 Outcomes

Т1/2 of Eculizumab(from 0 to 1392 hours post-infusion)
Emin CH50(from 0 to 1392 hours post-infusion)
Tmin CH50(from 0 to 1392 hours post-infusion)
Subjects With AEs/SAEs Related to Eculizumab(from 0 to 1392 hours post-infusion)
Cmax of Eculizumab(from 0 to 1392 hours post-infusion)
Тmax of Eculizumab(from 0 to 1392 hours post-infusion)
AUC0-1392 of Eculizumab(from 0 to 1392 hours post-infusion)
Vd of Eculizumab(from 0 to 1392 hours post-infusion)
ABEC(0-1392) CH50(from 0 to 1392 hours post-infusion)
AUEC(0-1392) CH50(from 0 to 1392 hours post-infusion)
Subjects Who Develop Grade 3/4 AEs Related to Eculizumab(from 0 to 1392 hours post-infusion)
Кel of Eculizumab(from 0 to 1392 hours post-infusion)
Cl of Eculizumab(from 0 to 1392 hours post-infusion)