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

Biocad57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

BCD-066BIOLOGICAL

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

AranespBIOLOGICAL

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

BIOCAD

Saint Petersburg, Strelna, Russia

Outcomes

Primary Outcomes

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

Time frame: 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

Cmax

The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®

Time frame: 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

The elimination half-life

Time frame: 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-∞)

The total area under the concentration curve from 0 to infinity

Time frame: 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

The time to maximum drug concentration in the serum

Time frame: 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

The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)

Time frame: 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

The total clearance

Time frame: 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

Data from ClinicalTrials.gov

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