Multiple Sclerosis, Relapsing-RemittingPhase 1NCT02517788
Phase I BP Interferon (IFN) Beta-004
A Phase 1 study testing Interferon beta-1a HSA-free biosimilar, Interferon beta-1a HSA+ biosimilar and Interferon beta-1a original in people with Multiple Sclerosis, Relapsing-Remitting, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
Phase I study aiming at: establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU; investigating the possible impact of albumin on pharmacokinetic profile by comparing 3… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Interferon beta-1a HSA-free biosimilar, Interferon beta-1a HSA+ biosimilar and Interferon beta-1a original
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged between 18 and 45 years
- Weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body mass index (BMI) was between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination
- Absence of significant laboratory abnormalities as judged by the investigator.
- 12-lead ECG without significant abnormalities
- Negative urine drug screen
Who cannot join
- History of major renal, hepatic, immunological, haematological, gastrointestinal, genitourinary, neurological, or rheumatological disorders
- Active diseases of any type, even if mild, including inflammatory disorders and infections.
- Pregnant or lactating women or women contemplating becoming pregnant during study. Female subjects of child-bearing potential who did not practice efficient contraception during the study. A pregnancy test in blood was performed at screening and before each period with β-human chorionic gonadotropin for females of child-bearing potential. If pregnancy test was positive, the subject had to be immediately excluded from study and followed until delivery
- History of severe allergy or of asthma at any time.
- History of cardiovascular dysfunction
- Hypertension
Show all 26Show fewer
- Sick sinus syndrome or known long QT syndrome
- Presence of QTc  > 440 msec or pronounced sinus bradycardia (<40 bpm/min), even if elicited by sport
- Dark skin preventing local tolerance assessment or abnormal cutaneous reaction e.g. urticaria or papular dermographism
- Intense sport activities.
- Any clinically significant laboratory value on screening that were not within normal range on single repeat
- Positive hepatitis B \& C antigen screen
- Positive HIV antibody screen or screen not performed
- Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study
- Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
- History of hypersensitivity to any drug if considered as serious
- History of alcohol or drug abuse
- Positive qualitative urine drug test at screening
- Use of any medication in 2 weeks prior to study and throughout study, including aspirin or other over-the-counter preparation.
- Blood (500 mL) donation or hemorrhage during the previous three months
- Participation in a clinical trial in the previous 3 months
- Smoking
- Consumption of a large quantity of coffee, tea or equivalent
- Present consumption of a large quantity of alcohol or wine or equivalent
- Psychological status which could have had an impact on subject's ability to give informed consent or behavioral tests
- Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject
About this study
Official title: Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy Subjects
Phase I study aiming at:
- establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU;
- investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif® from Merck-Serono, a registered IFN beta-1a solution containing HSA;
- establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals against Rebif® using the same regimen.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Interferon beta-1a HSA-free biosimilar, Interferon beta-1a HSA+ biosimilar, Interferon beta-1a original
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1a HSA-free biosimilarDrug
Also called Bioferon®
6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution without albumin
Interferon beta-1a HSA+ biosimilarDrug
Also called Bioferon®
6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution combined with albumin solution
Interferon beta-1a originalDrug
Also called Rebif®
6 MIU/0.50 mL in pre-filled glass syringe solubilized in HSA and mannitol solution (marketed formulation)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Interferon beta-1a in HSA-free solution | Experimental | Twelve subjects will participate in 3 periods of part A, receiving 18 MIU biosimilar interferon beta-1a without albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. Receives: Drug: Interferon beta-1a HSA-free biosimilar |
| Part A: Interferon beta-1a combined with HSA+ solution | Experimental | Twelve subjects will participate in 3 periods of part A, receiving 18 MIU biosimilar interferon beta-1a with albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. Receives: Drug: Interferon beta-1a HSA+ biosimilar |
| Part A: Interferon beta-1a in marketed HSA+ solution | Active comparator | Twelve subjects will participate in 3 periods of part A, receiving 18 MIU original interferon beta-1a with albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. Receives: Drug: Interferon beta-1a original |
| Part B: Interferon beta-1a in HSA-free solution | Experimental | Twelve additional volunteers will participate in part B, receiving 4 x 18 MIU biosimilar interferon beta-1a with albumin as s.c. doses at 48 hours intervals as 3 pre-filled syringes (3 sites 1 cm apart in abdominal wall on each dosing day, alternating right side for odd dose [i.e. dose 1 and 3] and left side for even dose [i.e. dose 2 and 4]). Receives: Drug: Interferon beta-1a HSA-free biosimilar |
| Part B: Interferon beta-1a in marketed HSA+ solution | Active comparator | Part B: Twelve additional volunteers will participate in part B, receiving 4 x 18 MIU original interferon beta-1a with albumin as s.c. doses at 48 hours intervals as 3 pre-filled syringes (3 sites 1 cm apart in abdominal wall on each dosing day, alternating right side for odd dose [i.e. dose 1 and 3] and left side for even dose [i.e. dose 2 and 4]). Receives: Drug: Interferon beta-1a original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of interferon beta-1a PK parameters
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and maximum observed concentration (Cmax) following single dose administration, as well as time to Cmax (tmax; for s.c. injection) will be assessed. Mean residence time (MRT), half-life of elimination (t1/2), clearance (CL), and volume of distribution at steady-state (Vss) will be calculated.
Measured: Part A: 0, 2, 5, 10, 15, 20 [min post-dose] and 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-dose] / Part B: 0, 1, 2, 3, 4, 6, 12 [hours post-doses] and 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)
Secondary outcomes (7)
Serum concentration of neopterin (PD marker)
Assessment by ELISA after i.v. and after s.c
Measured: Part A: 0, 6, 12, 24, 48, 72, 168 [hours post-doses] / Part B: 0, 6, 12 [hours post-doses] and 0, 6, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)
Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability
AE/SAE will be collected from the start of study treatment and until the follow-up visit
Measured: Up to Day 7
Composite of local reactions as a measure of local tolerance
Any local symptoms rated as moderate (grade 3 for i.v. and 2 for s.c.) or severe (grade 4 and 5 for i.v.; grade 3 for s.c.) will be reported as an adverse event. The subjective painful sensation following injection of the drug will be assessed using a visual analogue scale (VAS)
Measured: Part A: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose] and longer if needed and until resolution in case of local reaction / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose] on Day 1 and 7, else daily up to Day 9 longer until resolution
Composite of clinical laboratory tests as a measure of safety and tolerability
Clinical laboratory tests will include hematology, clinical chemistry and urinalysis
Measured: Screening and 0, 24 [hours post-doses]
Composite of vital signs as a measure of safety and tolerability
Vital signs will include body temperature, blood pressure and heart rate
Measured: Part A: Screening and 0, 1, 2, 3, 4, 6, 8, 10, 12, 24 [hours post-dose] / Part B: Screening and 0, 1, 2, 3, 4, 6, 12 [hours post-doses], as well as 0, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-last dose] (Day 7)
Sickness behavior assessment
Four parameters will be recorded (general feeling, headache, muscle ache, mood)
Measured: Part A: 0, 2, 4, 6, 8, 10, 12 [hours post-dose] / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose], as well as 24, 48, 72 [hours post-last dose] (Day 7)
Electrocardiogram (ECG) as a measure of safety and tolerability
Twelve-lead ECG will be recorded
Measured: Screening and 0, 3 [hours post-dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMay 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- BioPartners GmbH
- Responsible party
- Principal investigator, Prof. Jérôme Biollaz, MD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jérôme Biollaz, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517788
- Sponsor's protocol ID
- CE 93/06
- Other IDs
- 2006DR1162
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perrottet N, Brunner-Ferber F, Grouzmann E, Spertini F, Biollaz J, Buclin T, Widmer N. Biases affecting injected doses of an experimental drug during clinical trials. Trials. 2016 Jul 16;17(1):321. doi: 10.1186/s13063-016-1463-5.
PubMed 27423899
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02517788
- Acronym / sponsor ID
- CE 93/06
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- BioPartners GmbH
- Study start
- May 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study aiming at:
- establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU;
- investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif® from Merck-Serono, a registered IFN beta-1a solution containing HSA;
- establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals against Rebif® using the same regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Interferon beta-1a in HSA-free solution | Experimental | Drug: Interferon beta-1a HSA-free biosimilarTwelve subjects will participate in 3 periods of part A, receiving 18 MIU biosimilar interferon beta-1a without albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. |
| Part A: Interferon beta-1a combined with HSA+ solution | Experimental | Drug: Interferon beta-1a HSA+ biosimilarTwelve subjects will participate in 3 periods of part A, receiving 18 MIU biosimilar interferon beta-1a with albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. |
| Part A: Interferon beta-1a in marketed HSA+ solution | Active comparator | Drug: Interferon beta-1a originalTwelve subjects will participate in 3 periods of part A, receiving 18 MIU original interferon beta-1a with albumin as i.v. bolus into a distal port under constant saline infusion as 3 treatments. |
| Part B: Interferon beta-1a in HSA-free solution | Experimental | Drug: Interferon beta-1a HSA-free biosimilarTwelve additional volunteers will participate in part B, receiving 4 x 18 MIU biosimilar interferon beta-1a with albumin as s.c. doses at 48 hours intervals as 3 pre-filled syringes (3 sites 1 cm apart in abdominal wall on each dosing day, alternating right side for odd dose [i.e. dose 1 and 3] and left side for even dose [i.e. dose 2 and 4]). |
| Part B: Interferon beta-1a in marketed HSA+ solution | Active comparator | Drug: Interferon beta-1a originalPart B: Twelve additional volunteers will participate in part B, receiving 4 x 18 MIU original interferon beta-1a with albumin as s.c. doses at 48 hours intervals as 3 pre-filled syringes (3 sites 1 cm apart in abdominal wall on each dosing day, alternating right side for odd dose [i.e. dose 1 and 3] and left side for even dose [i.e. dose 2 and 4]). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects aged between 18 and 45 years
- Weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body mass index (BMI) was between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination
- Absence of significant laboratory abnormalities as judged by the investigator.
- 12-lead ECG without significant abnormalities
Key exclusion criteria (26 listed)
- History of major renal, hepatic, immunological, haematological, gastrointestinal, genitourinary, neurological, or rheumatological disorders
- Active diseases of any type, even if mild, including inflammatory disorders and infections.
- Pregnant or lactating women or women contemplating becoming pregnant during study. Female subjects of child-bearing potential who did not practice efficient contraception during the study. A pregnancy test in blood was performed at screening and before each period with β-human chorionic gonadotropin for females of child-bearing potential. If pregnancy test was positive, the subject had to be immediately excluded from study and followed until delivery
- History of severe allergy or of asthma at any time.
- History of cardiovascular dysfunction
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-1a HSA-free biosimilarAlso: Bioferon®6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution without albumin | Drug | Part A: Interferon beta-1a in HSA-free solution, Part B: Interferon beta-1a in HSA-free solution |
| Interferon beta-1a HSA+ biosimilarAlso: Bioferon®6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution combined with albumin solution | Drug | Part A: Interferon beta-1a combined with HSA+ solution |
| Interferon beta-1a originalAlso: Rebif®6 MIU/0.50 mL in pre-filled glass syringe solubilized in HSA and mannitol solution (marketed formulation) | Drug | Part A: Interferon beta-1a in marketed HSA+ solution, Part B: Interferon beta-1a in marketed HSA+ solution |
Primary outcome
Composite of interferon beta-1a PK parameters
Time frame: Part A: 0, 2, 5, 10, 15, 20 [min post-dose] and 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-dose] / Part B: 0, 1, 2, 3, 4, 6, 12 [hours post-doses] and 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and maximum observed concentration (Cmax) following single dose administration, as well as time to Cmax (tmax; for s.c. injection) will be assessed. Mean residence time (MRT), half-life of elimination (t1/2), clearance (CL), and volume of distribution at steady-state (Vss) will be calculated.
7 secondary outcomes
Serum concentration of neopterin (PD marker)
Time frame: Part A: 0, 6, 12, 24, 48, 72, 168 [hours post-doses] / Part B: 0, 6, 12 [hours post-doses] and 0, 6, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)
Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability
Time frame: Up to Day 7
Composite of local reactions as a measure of local tolerance
Time frame: Part A: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose] and longer if needed and until resolution in case of local reaction / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose] on Day 1 and 7, else daily up to Day 9 longer until resolution
Composite of clinical laboratory tests as a measure of safety and tolerability
Time frame: Screening and 0, 24 [hours post-doses]
Composite of vital signs as a measure of safety and tolerability
Time frame: Part A: Screening and 0, 1, 2, 3, 4, 6, 8, 10, 12, 24 [hours post-dose] / Part B: Screening and 0, 1, 2, 3, 4, 6, 12 [hours post-doses], as well as 0, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-last dose] (Day 7)
Sickness behavior assessment
Time frame: Part A: 0, 2, 4, 6, 8, 10, 12 [hours post-dose] / Part B: 0, 1, 2, 4, 6, 12 [hours post-dose], as well as 24, 48, 72 [hours post-last dose] (Day 7)
Electrocardiogram (ECG) as a measure of safety and tolerability
Time frame: Screening and 0, 3 [hours post-dose]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Derived from this study: PubMed 27423899Perrottet N, Brunner-Ferber F, Grouzmann E, Spertini F, Biollaz J, Buclin T, Widmer N. Biases affecting injected doses of an experimental drug during clinical trials. Trials. 2016 Jul 16;17(1):321. doi: 10.1186/s13063-016-1463-5.
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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.
Jérôme Biollaz, MD principal investigator
Centre Hospitalier Universitaire Vaudois
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interferon beta-1a HSA-free biosimilar, Interferon beta-1a HSA+ biosimilar and Interferon beta-1a original in people with Multiple Sclerosis, Relapsing-Remitting, run by Centre Hospitalier Universitaire Vaudois.
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 6 inclusion and 26 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of interferon beta-1a PK parameters (time frame: Part A: 0, 2, 5, 10, 15, 20 [min post-dose] and 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 [hours post-dose] / Part B: 0, 1, 2, 3, 4, 6, 12 [hours post-doses] and 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 [hours post-last dose] (Day 7)). 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 NCT02517788, which also lists 1 linked publication.
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 Aug 2015.