HealthyPhase 1NCT02359877
Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers
A Phase 1 study testing BCD-054, Rebif and Avonex in people with Healthy, run by Biocad at 1 site in Russia.
Trial summary
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. 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-054, Rebif and Avonex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2014to Dec 2015
- 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
None listed.
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 or pegylated proteins;
- 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);
Show all 19Show fewer
- History of fever over 40°С
- History of increase in aminotransferases (ALT, AST) > 2.5 × ULN
- History of epileptic seizures;
- Depression and/or suicidal ideas, suicide attempts in history
- 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 inclusion in the study;
- Vaccination within 4 weeks prior to inclusion
- 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.
About this study
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054.
- Conditions
- Healthy
- Being tested
- BCD-054, Rebif, Avonex
- Keywords
- pegylated interferon beta, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-054Drug
Also called pegylated interferon beta 1a
RebifDrug
Also called interferon beta 1a
AvonexDrug
Also called interferon beta 1a
| Study group | Role | What they receive |
|---|---|---|
| BCD-054 | Experimental | Pegylated interferon beta 1a Single doses - 60 mcg, SC/IM Single doses - 120 mcg, SC/IM Single doses - 240 mcg, SC/IM Single doses - 360 mcg, SC/IM Multiple doses - 180 mcg, SC/IM Receives: Drug: BCD-054 |
| Rebif | Active comparator | interferon beta 1a 44 mcg, SC, 3 times a week for 2 weeks Receives: Drug: Rebif |
| Avonex | Active comparator | interferon beta 1a 30 mcg, IM, once a week for 2 weeks Receives: Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a
Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively
Measured: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM
Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration
Measured: 0 to 672 hours
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin
Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively
Measured: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
AUC(0-∞), AUC(0-last) of Neopterin
Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration
Measured: 0 to 672 hours
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence
Stage 1
Measured: 4 weeks
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM
Stage 2 BCD-054 - 180 mcg - SC/IM
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionDec 2015
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan Sardaryan, PhD, Principal investigator, OOO BioEk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359877
- Sponsor's protocol ID
- BCD-054-1
- Status last verified
- Apr 2017
- First submitted
- 20 Jan 2015
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02359877
- Acronym / sponsor ID
- BCD-054-1
- Conditions
- Healthy
- Keywords
- pegylated interferon beta, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 23 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCD-054 | Experimental | Drug: BCD-054Pegylated interferon beta 1a Single doses - 60 mcg, SC/IM Single doses - 120 mcg, SC/IM Single doses - 240 mcg, SC/IM Single doses - 360 mcg, SC/IM Multiple doses - 180 mcg, SC/IM |
| Rebif | Active comparator | Drug: Rebifinterferon beta 1a 44 mcg, SC, 3 times a week for 2 weeks |
| Avonex | Active comparator | Drug: Avonexinterferon beta 1a 30 mcg, IM, once a week for 2 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 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 or pegylated proteins;
- 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 |
|---|---|---|
| BCD-054Also: pegylated interferon beta 1a | Drug | BCD-054 |
| RebifAlso: interferon beta 1a | Drug | Rebif |
| AvonexAlso: interferon beta 1a | Drug | Avonex |
Primary outcome
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a
Time frame: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively
AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM
Time frame: 0 to 672 hours
Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin
Time frame: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively
AUC(0-∞), AUC(0-last) of Neopterin
Time frame: 0 to 672 hours
Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence
Time frame: 4 weeks
Stage 1
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM
Time frame: 4 weeks
Stage 2 BCD-054 - 180 mcg - SC/IM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
OOO BioEk
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-054, Rebif and Avonex 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 0 inclusion and 19 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 10 Apr 2017. 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 23 Dec 2016). 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 (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a (time frame: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2017.