Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers

NCT02731469 | Completed Phase 1 Results

• 1 other identifier: BCD-131-1
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers

Conditions

Reticulocyte Count

Outcome Measures

Primary Outcomes (1)

• AUC (0-1176 Hours)

  Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose

Secondary Outcomes (15)

• Cmax

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

• Tmax

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

• T1/2

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

• Kel

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

• Clearance of BCD-131

  0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Study Arms (11)

BCD-131, 0.05 mcg/kg subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 0.05 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 0.15 mcg/kg subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 0.15 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 0.40 mcg/kg subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 0.40 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 1.05 mcg/kg subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 1.05 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 1.70 mcg/kg SC

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 1.70 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 2.25 mcg/kg SC

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 2.25 mcg/kg subcutaneously

Biological: BCD-131

BCD-131, 4.45 mcg/kg subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in a dose 4.45 mcg/kg subcutaneously

Biological: BCD-131

Mircera®, 1.20 mcg/kg subcutaneously

ACTIVE COMPARATOR

Healthy volunteers will receive Mircera in a dose 1.20 mcg/kg subcutaneously

Biological: Mircera®

Aranesp®, 0.45 mcg/kg subcutaneously

ACTIVE COMPARATOR

Healthy volunteers will receive BCD-131 in a dose 0.45 mcg/kg subcutaneously

Biological: Aranesp®

BCD-131, optimal dose, intravenously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial intravenously

Biological: BCD-131

BCD-131, optimal dose, subcutaneously

EXPERIMENTAL

Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial subcutaneously

Biological: BCD-131

Interventions

BCD-131 BIOLOGICAL

Also known as: pegylated darbepoetin alfa

BCD-131, 0.05 mcg/kg subcutaneously; BCD-131, 0.15 mcg/kg subcutaneously; BCD-131, 0.40 mcg/kg subcutaneously; BCD-131, 1.05 mcg/kg subcutaneously; BCD-131, 1.70 mcg/kg SC; BCD-131, 2.25 mcg/kg SC; BCD-131, 4.45 mcg/kg subcutaneously; BCD-131, optimal dose, intravenously; BCD-131, optimal dose, subcutaneously

Mircera® BIOLOGICAL

Also known as: Methoxy polyethylene glycol-epoetin beta

Mircera®, 1.20 mcg/kg subcutaneously

Aranesp® BIOLOGICAL

Also known as: darbepoetin alfa

Aranesp®, 0.45 mcg/kg subcutaneously

Eligibility Criteria

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

You may qualify if:

• Signing of the Informed Consent Form;
• Male sex;
• Age of 18 to 45 years, inclusive;
• BMI within normal limits (18.5-24.9 kg/m2);
• Healthy patients, which is proved by their medical history, physical examination and laboratory findings:
• No clinically significant abnormalities of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys in the past medical history and at screening;
• No history of cardiovascular disorders or thyroid disorders;
• No history of hematologic disorders, including but not limited to any type of anemia, myelodysplastic syndrome, blood cancers, hemolytic syndrome, hemoglobinopathies, coagulopathies;
• CBC results within normal limits, including:
• Hemoglobin within 132-173 g/L;
• Hematocrit (based on CBC results) within 39-49%;
• Platelet count within 150-400\*109/L;
• Absolute reticulocyte count within 30.4-93.5 \* 109/L;
• Blood biochemistry and urinalysis results within normal limits;
• Serum ferritin within 20-250 µg/L;

You may not qualify if:

• History of treatment with erythropoietins or any other ESAs;
• History of chronic bleeding;
• Standard laboratory and instrumental findings outside normal limits at screening;
• History of allergies (anaphylactic shock or multiple drug allergy syndrome);
• Known allergy or intolerance to any components of the investigational product;
• Major surgery within 30 days prior to screening, or surgery being scheduled for any time during the study;
• Impossibility to install a venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);
• Diseases or other conditions that can interfere with the pharmacokinetics of the investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others);
• History of fever of 40 °C or more;
• History of elevated hepatic transaminases (above 2.5xULN);
• History of epileptic attacks or seizures;
• History or current (at screening) depression, suicidal thoughts/ attempts;
• Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within 2 weeks before a scheduled injection of the test drug;
• Use of drugs, including OTC products, that significantly affect the hemodynamics, hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before a scheduled injection of the test drug;
• Vaccination within 4 weeks before a scheduled injection of the test drug;

Sponsors & Collaborators

• Biocad: lead

MeSH Terms

Interventions

continuous erythropoietin receptor activator; Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Yulia Linkova Medical Director
• Organization: Biocad

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 7, 2016
• Study Start: June 15, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share