The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers

NCT03693950 | Completed Phase 1 Results

• 1 other identifier: BCD-066-3
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of BCD-066 and Aranesp®. The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC(0-72)

  The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose

Secondary Outcomes (6)

• Cmax

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose

• T½

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose

• AUC(0-∞)

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose

• Tmax

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose

• Kel

  5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose

Study Arms (2)

BCD-066 1 µg/kg

EXPERIMENTAL

Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.

Biological: BCD-066

Aranesp 1 µg/kg

ACTIVE COMPARATOR

Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.

Biological: Aranesp

Interventions

BCD-066 BIOLOGICAL

BCD-066 will be administered once a week intravenously in a dose 1 µg/kg

Also known as: darbepoetin alfa

BCD-066 1 µg/kg

Aranesp BIOLOGICAL

Aranesp will be administered once a week intravenously in a dose 1 µg/kg

Also known as: darbepoetin alfa

Aranesp 1 µg/kg

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form
• Men from 18 to 45 years old (inclusive)
• BMI within the normal limits (18.5 to 30 kg/m2)
• Hemoglobin from 120 g/L to 150 g/L and hematocrit 41% to 49% at screening (before the first injection)
• Serum transferring 2.15 g/L to 3.6 g/L; serum ferritin from 20 μg/L to 250 μg/L
• Vitamin B12 from 187 pcg/mL to 883 pcg/mL; folic acid from 3.1 ng/mL to 20.5 ng/mL
• Endogenous serum erythropoietin \< 30 mIU/mL at screening
• The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests
• Subject's ability (in the investigator's opinion) to follow the protocol procedures
• The subject agrees not to drink alcohol for 24 h prior to each injection of the test/reference drug and for 72 h after the injection.

You may not qualify if:

• \. Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol 2. Acute infections within 4 weeks before the study start 3. Results of laboratory and/or instrumental tests are outside the normal range 4. Chronic cardiovascular, bronchial and/or pulmonary, neuroendocrine GI, liver, kidney, and blood diseases, including ischemic heart disease, arterial hypertension, peripheral vascular and/or cerebral vascular disorders, and thrombocytosis 5. A history of chronic hemorrhages

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

BIOCAD

Saint Petersburg, Strelna, 198515, Russia

Location

MeSH Terms

Interventions

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 ext. 930

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: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: March 28, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: April 21, 2020
• Results First Posted: July 1, 2019

Record last verified: 2020-04

Locations

RU (1)