HealthyPhase 1NCT01766024

Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers

A Phase 1 study testing Interferon beta-1a 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.

Official record

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Trial summary

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?: Interferon beta-1a
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteRussia
Study dates: Feb 2013to Jun 2013
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

Written informed consent;
Male gender;
Age 18 - 45 years inclusive;
Body mass index (BMI) (18,5 - 24,99 kg/m2);
Healthy condition proven by the volunteer's history, global assessment and laboratory analysis results:
Absence in past medical history and at screening of clinically significant dysfunctions of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys;

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Haematology and biochemistry tests, urinalysis and thyroid hormone analysis results are within normal limits according to standards of the study site. Screening laboratory analyses should be performed not more than 14 days before volunteer's inclusion in the study;
Hemodynamic parameters are within normal limits: systolic blood pressure - from 100 to 139 mmHg, diastolic blood pressure - from 60 to 90 mmHg, heart rate - from 50 to 90 bpm;
Absence of history of chronic infection (tuberculosis) and chronic inflammation;
Absence of HIV, hepatitis B and C virus, syphilis;
Absence of acute infections within 4 weeks before inclusion in the study;
Absence of psychiatric disorders and other conditions that can interfere with volunteer's ability to follow the study protocol, including depression;
Well-being (in volunteer's opinion) within 30 days before participation in the study;
Absence of history of systematic alcohol and drug abuse;
Ability of the volunteer, in investigator's opinion, to follow the study protocol procedures and requirements;
Willingness of volunteers and their sexual partners of childbearing potential to use reliable contraception methods starting from 2 weeks before inclusion into the study and until 4 weeks after receiving the last dose of the investigational products. This criterion is not applicable to patients who underwent surgical sterilization. Reliable contraceptive measures include one barrier method in combination with one of the following methods: spermicides, intrauterine device or oral contraceptives used by participant's partner;
Consent to avoid alcohol intake within 24 hours before and 8 days after each administration of the test or reference drugs;
Consent to avoid grapefruit juice (or other products containing grapefruit) intake within 72 hours before and 8 days after each administration of the study or reference drugs.

Who cannot join

Previous use of IFN-β1-containing medications at any time before inclusion;
History of serious allergic reactions (anaphylaxis or multiple allergy);
Known allergy or intolerance to interferons or any other components of study or reference drugs;
Major surgery within 30 days before screening;
Impossibility to install venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);
Diseases or other conditions that can interfere with the investigational drugs pharmacokinetics (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others);

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History of epileptic seizures;
Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within less than 2 weeks before inclusion in the study;
Intake of medications, including over-the-counter drugs and biologically active additives that can influence hemodynamics, liver function etc. (barbiturates, omeprazole, cimetidine etc.) within less than 30 days before inclusion in the study;
Intake of medications that influence immune status (cytokines and their inductors, glucocorticoids etc.) within less than 30 days before participation in the study;
Smoking more than 10 cigarettes per day;
Subjects who consume more than 10 units of alcohol per week or who have history of alcohol abuse or evidence of drug/chemical abuse (one unit of alcohol equals ½ l [500 ml] of beer, one glass [200 ml] of wine or l shot glass [50 ml] of spirits);
Donation of 450 ml and more of blood or plasma within 2 months before inclusion in the study;
Participation in other clinical studies within less than 1 month before inclusion in the study or simultaneous participation in another clinical study;
Previous participation in this study

Trial locations and contacts

1 site in 1 country.

Russia1 site

City Mariin Hospital
Saint Petersburg, 194104

Other trials in Russia

About this study

Official title: International Multicenter Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Tolerability of BCD-033 (CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.А., Italy) After Single Subcutaneous Administration to Healthy Volunteers

This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability parameters after single subcutaneous injection. Each dtug will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Read the detailed description

Each dtug (BCD-033 and Rebif) will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Conditions: Healthy
Being tested: Interferon beta-1a
Keywords: interferon beta-1a, pharmacokinetics, pharmacodynamics, volunteers

What participants receive

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

Interferon beta-1aDrug
Also called BCD-033, Rebif
Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Study groups in NCT01766024
Study group	Role	What they receive
BCD-033 → Rebif	Experimental	Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg. Receives: Drug: Interferon beta-1a
Rebif → BCD-033	Experimental	Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg. Receives: Drug: Interferon beta-1a

What is being measured

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

Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)
Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.
Measured: 0 to 48 hours post-dose
Cmax of Interferon Beta-1a
Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.
Measured: 0 to 48 hours post-dose
AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein
Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.
Measured: 0 to 168 hours post-dose

Secondary outcomes (10)

Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Secondary outcome measure for pharmacokinetics analysis
Measured: 0 to 48 hours post-dose
Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Secondary outcome measure for pharmacokinetics analysis
Measured: 0 to 48 hours post-dose
Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Secondary outcome measure for pharmacokinetics analysis
Measured: 0 to 48 hours post-dose
Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Secondary outcome measure for pharmacokinetics analysis
Measured: 0 to 48 hours post-dose
Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.
Secondary outcome measure for pharmacodynamics analysis
Measured: 0 to 168 hours post-dose
Tmax of Neopterin and MxA Protein
Secondary outcome measure for pharmacodynamics analysis
Measured: 0 to 168 hours post-dose
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence
Secondary outcome measure for safety assessment
Measured: up to Day 43
AE of Garde 3-4 Incidence
Secondary outcome measure for safety assessment
Measured: up to Day 43
Local Reaction Incidence
Secondary outcome measure for tolerability assessment
Measured: up to Day 43
Study Withdrawal Rate Due to AE
Secondary outcome measure for safety assessment
Measured: up to Day 43

Timeline

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

Feb 2013Jun 2013

First posted11 Jan 2013 (estimated)
Study startFeb 2013
Primary completionJun 2013
Study completionJun 2013

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01766024
Sponsor's protocol ID: BCD-033-1
Status last verified: Mar 2016
First submitted: 10 Jan 2013
Last updated: 4 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Multicenter Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Tolerability of BCD-033 (CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.А., Italy) After Single Subcutaneous Administration to Healthy Volunteers
ClinicalTrials.gov ID: NCT01766024
Acronym / sponsor ID: BCD-033-1
Conditions: Healthy
Keywords: interferon beta-1a, pharmacokinetics, pharmacodynamics, volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 11 Jan 2013 (estimated)
Results: Posted 16 Feb 2015

Clinical summary

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

Detailed description

Each dtug (BCD-033 and Rebif) will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BCD-033 → Rebif	Experimental	Drug: Interferon beta-1aVolunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.
Rebif → BCD-033	Experimental	Drug: Interferon beta-1aVolunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.

Who may qualify

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

Key inclusion criteria (18 listed)

Written informed consent;
Male gender;
Age 18 - 45 years inclusive;
Body mass index (BMI) (18,5 - 24,99 kg/m2);
Healthy condition proven by the volunteer's history, global assessment and laboratory analysis results:

Key exclusion criteria (15 listed)

Previous use of IFN-β1-containing medications at any time before inclusion;
History of serious allergic reactions (anaphylaxis or multiple allergy);
Known allergy or intolerance to interferons or any other components of study or reference drugs;
Major surgery within 30 days before screening;
Impossibility to install venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);

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
Interferon beta-1aAlso: BCD-033, RebifEach volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.	Drug	BCD-033 → Rebif, Rebif → BCD-033

Primary outcome

Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)
Time frame: 0 to 48 hours post-dose
Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.
Cmax of Interferon Beta-1a
Time frame: 0 to 48 hours post-dose
Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.
AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein
Time frame: 0 to 168 hours post-dose
Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.

10 secondary outcomes

Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Time frame: 0 to 48 hours post-dose
Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Time frame: 0 to 48 hours post-dose
Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Time frame: 0 to 48 hours post-dose
Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.
Time frame: 0 to 48 hours post-dose
Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.
Time frame: 0 to 168 hours post-dose
Tmax of Neopterin and MxA Protein
Time frame: 0 to 168 hours post-dose
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence
Time frame: up to Day 43
AE of Garde 3-4 Incidence
Time frame: up to Day 43
Local Reaction Incidence
Time frame: up to Day 43
Study Withdrawal Rate Due to AE
Time frame: up to Day 43

Results and safety

Results posted to the registry on 16 Feb 2015, 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-033 → Rebif	16	16
Rebif → BCD-033	16	16

Primary outcome: Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)

Time frame: 0 to 48 hours post-dose. Median (Inter-Quartile Range). Unit: (pg/ml)•h

Measure	BCD-033 n = 30	Rebif n = 30
Value	6318.3 (5368.4 to 7484.9)	6807.9 (5714.9 to 8920.1)

Primary outcome: Cmax of Interferon Beta-1a

Time frame: 0 to 48 hours post-dose. Median (Inter-Quartile Range). Unit: pg/ml

Measure	BCD-033 n = 30	Rebif n = 30
Value	104.9 (80.2 to 123.4)	102.4 (83.6 to 148.6)

Primary outcome: AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein

Time frame: 0 to 168 hours post-dose. Median (Inter-Quartile Range). Unit: (ng/ml)*h

Measure	BCD-033 n = 32	Rebif n = 32
neopterin	552.7 (458.1 to 661.6)	537.6 (392.6 to 680.1)
MxA protein	2444.2 (2005.5 to 3011.2)	2131.2 (1728.0 to 3245.0)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCD-033	0 of 32 (0%)	32 of 32 (100%)	Not reported
Rebif	0 of 32 (0%)	32 of 32 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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.

Ivan Sardaryan, PhD principal investigator

City Mariin Hospital

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 Interferon beta-1a 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 18 inclusion and 15 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 4 May 2016. 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 16 Feb 2015). 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?

Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively) (time frame: 0 to 48 hours post-dose). The study lists 3 primary outcomes in all. 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 NCT01766024.

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 4 May 2016.