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

NCT04027803 | Completed Phase 1 Results

• 1 other identifier: BCD-148-3
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• AUC0-∞ of Eculizumab

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

  from 0 to 1392 hours post-infusion

Secondary Outcomes (13)

• 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

• Т1/2 of Eculizumab

  from 0 to 1392 hours post-infusion

• Vd of Eculizumab

  from 0 to 1392 hours post-infusion

Study Arms (2)

BCD-148

EXPERIMENTAL

39 healthy subjects received BCD-148, 900 mg, a single drip infusion over 25-45 min

Biological: BCD-148

Soliris

ACTIVE COMPARATOR

39 healthy subjects received Soliris, 900 mg, a single drip infusion over 25-45 min

Biological: Soliris

Interventions

BCD-148 BIOLOGICAL

single intravenous infusion of BCD-148 (900 mg)

Also known as: eculizumab

BCD-148

Soliris BIOLOGICAL

single intravenous infusion of Soliris (900 mg)

Also known as: eculizumab

Soliris

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

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

Saint Petersburg, Russia

Location

MeSH Terms

Interventions

eculizumab

Results Point of Contact

• Title: Morozova Maria
• Organization: BIOCAD

morozovama@biocad.ru

+7 (495) 992 66 28

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 22, 2019
• Study Start: September 21, 2018
• Primary Completion: April 7, 2019
• Study Completion: April 7, 2019
• Last Updated: May 15, 2020
• Results First Posted: May 15, 2020

Record last verified: 2020-05

Locations

RU (1)