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

NCT ID: NCT03693950

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2017-07-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

BCD-066 1 µg/kg

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

Group Type: EXPERIMENTAL

BCD-066

Intervention Type: BIOLOGICAL

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

Aranesp 1 µg/kg

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

Group Type: ACTIVE_COMPARATOR

Aranesp

Intervention Type: BIOLOGICAL

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

Interventions

BCD-066

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

Intervention Type: BIOLOGICAL

Aranesp

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

Intervention Type: BIOLOGICAL

Other Intervention Names

darbepoetin alfa; darbepoetin alfa

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent form

2. Men from 18 to 45 years old (inclusive)

3. BMI within the normal limits (18.5 to 30 kg/m2)

4. Hemoglobin from 120 g/L to 150 g/L and hematocrit 41% to 49% at screening (before the first injection)

5. Serum transferring 2.15 g/L to 3.6 g/L; serum ferritin from 20 μg/L to 250 μg/L

6. Vitamin B12 from 187 pcg/mL to 883 pcg/mL; folic acid from 3.1 ng/mL to 20.5 ng/mL

7. Endogenous serum erythropoietin < 30 mIU/mL at screening

8. The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests

9. Subject's ability (in the investigator's opinion) to follow the protocol procedures

10. The subject and his sexual partner with retained childbearing potential consent to implement reliable contraceptive methods starting 2 weeks before inclusion in the study and up to 2 weeks after the last dose of the test/reference drug. This requirement does not apply to surgically sterile subjects. 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.

11. 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.

Exclusion Criteria

1. 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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Ivanov, PhD

Role: STUDY_CHAIR

JCS BIOCAD

Locations

BIOCAD

Saint Petersburg, Strelna, Russia

Countries

Russia

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

BCD-066-3

Identifier Type: -

Identifier Source: org_study_id