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

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ClinicalTrials.gov Identifier: NCT03693950
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

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.


Condition or disease Intervention/treatment Phase
Healthy Biological: BCD-066 Biological: Aranesp Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: A Double-blind, Randomized, Controlled Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Multiple Intravenous Injections of BCD-066 and Aranesp® in Healthy Volunteers
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : July 3, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: BCD-066
BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
Other Name: darbepoetin alfa

Active Comparator: 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.
Biological: Aranesp
Aranesp will be administered once a week intravenously in a dose 1 µg/kg
Other Name: darbepoetin alfa




Primary Outcome Measures :
  1. 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 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


Secondary Outcome Measures :
  1. Cmax [ 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 ]
    The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®

  2. T½ [ 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 elimination half-life

  3. AUC(0-∞) [ 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 area under the concentration curve from 0 to infinity

  4. Tmax [ 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 time to maximum drug concentration in the serum

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

  6. CL [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693950


Locations
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Russian Federation
BIOCAD
Saint Petersburg, Strelna, Russian Federation, 198515
Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JCS BIOCAD
  Study Documents (Full-Text)

Documents provided by Biocad:
Informed Consent Form  [PDF] June 2, 2016
Statistical Analysis Plan  [PDF] October 2, 2016
Study Protocol  [PDF] October 2, 2016


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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03693950     History of Changes
Other Study ID Numbers: BCD-066-3
First Posted: October 3, 2018    Key Record Dates
Results First Posted: July 1, 2019
Last Update Posted: July 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Darbepoetin alfa
Hematinics