HealthyPhase 1NCT03693950

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

A Phase 1 study testing BCD-066 and Aranesp in people with Healthy, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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®. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BCD-066 and Aranesp
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteRussia
Study dates: 28 Mar 2017to 3 Jul 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 11Show fewer

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 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.
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.

Who cannot join

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
-

Trial locations and contacts

1 site in 1 country.

Russia1 site

BIOCAD
Saint Petersburg, Strelna, 198515

Other trials in Russia

About this study

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

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
Being tested: BCD-066, Aranesp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCD-066Biological
Also called darbepoetin alfa
BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
AranespBiological
Also called darbepoetin alfa
Aranesp will be administered once a week intravenously in a dose 1 µg/kg

Study groups in NCT03693950
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Aranesp

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
CL
The total clearance
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 20173 Jul 2017

First posted3 Oct 2018
Study start28 Mar 2017
Primary completion3 Jul 2017
Study completion3 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03693950
Sponsor's protocol ID: BCD-066-3
Status last verified: Apr 2020
First submitted: 1 Oct 2018
Last updated: 21 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03693950
Acronym / sponsor ID: BCD-066-3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: 28 Mar 2017 (actual)
Primary completion: 3 Jul 2017 (actual)
Study completion: 3 Jul 2017 (actual)
First posted: 3 Oct 2018 (actual)
Results: Posted 1 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
BCD-066 1 µg/kg	Experimental	Biological: BCD-066Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp 1 µg/kg	Active comparator	Biological: AranespHealthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (2 listed)

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
-

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCD-066Also: darbepoetin alfaBCD-066 will be administered once a week intravenously in a dose 1 µg/kg	Biological	BCD-066 1 µg/kg
AranespAlso: darbepoetin alfaAranesp will be administered once a week intravenously in a dose 1 µg/kg	Biological	Aranesp 1 µg/kg

Primary outcome

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

6 secondary outcomes

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
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
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
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
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
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

Results and safety

Results posted to the registry on 1 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BCD-066 1 µg/kg	29	28
Aranesp 1 µg/kg	28	28

Primary outcome: 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. Median (Inter-Quartile Range). Unit: pg/ml·h

Measure	BCD-066 1 µg/kg n = 28	Aranesp 1 µg/kg n = 28
Value	328215.65 (275530.49 to 401053.38)	290827.12 (252607.47 to 349760.35)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCD-066 1 µg/kg	0 of 28 (0%)	5 of 28 (17.9%)	0 of 28
Aranesp 1 µg/kg	0 of 28 (0%)	16 of 28 (57.1%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roman Ivanov, PhD study chair

JCS BIOCAD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-066 and Aranesp in people with Healthy, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.