Central Nervous System (CNS) Demyelinating DiseasePhase 1NCT02641041
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants
A Phase 1 study testing BIIB033 in people with Central Nervous System (CNS) Demyelinating Disease and Multiple Sclerosis, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System (CNS) Demyelinating Disease, Multiple Sclerosis
- What is being tested?
- BIIB033
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Sep 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
- Must be a nonsmoker or light smoker (<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
- Must have a body mass index of 18 to 32 kg/m2, inclusive.
Who cannot join
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day -1.
- Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
- History of severe allergic or anaphylactic reactions.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects
The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.
- Being tested
- BIIB033, Placebo
- Keywords
- Japanese, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD)
- Medical subject headings
- Demyelinating Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB033Biological
single or multiple dose
PlaceboOther
single or multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1 Receives: Biological: BIIB033; Other: Placebo |
| Cohort 2 | Experimental | A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1 Receives: Biological: BIIB033; Other: Placebo |
| Cohort 3 | Experimental | One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15 Receives: Biological: BIIB033; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to day 113
Number of participants with clinically significant laboratory parameters
Measured: Up to day 113
Number of participants with clinically significant vital sign abnormalities
Measured: Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Measured: Up to day 113
Number of participants with clinically significant physical examination abnormalities
Measured: Up to day 113
Number of participants with clinically significant neurological examination abnormalities
Measured: Up to day 113
Secondary outcomes (10)
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)
Measured: Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Measured: Up to day 113
PK parameter of BIIB033: AUC over a given dosing interval
Measured: Up to day 113
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Measured: Up to day 113
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
Measured: Up to day 113
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
Measured: Up to day 113
PK parameter of BIIB033: Volume of distribution at steady state (Vss)
Measured: Up to day 113
PK parameter of BIIB033: Clearance (CL)
Measured: Up to day 113
PK parameter of BIIB033: accumulation ratio (RAC)
Measured: Up to day 113
Number of participants with positive serum BIIB033 antibodies
Measured: Up to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System (CNS) Demyelinating DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641041
- Sponsor's protocol ID
- 215HV102
- Other IDs
- 2015-004560-11, 2015
- Status last verified
- Oct 2016
- First submitted
- 23 Dec 2015
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02641041
- Acronym / sponsor ID
- 215HV102
- Keywords
- Japanese, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Dec 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.
The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: BIIB033, Other: PlaceboA single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 2 | Experimental | Biological: BIIB033, Other: PlaceboA single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 3 | Experimental | Biological: BIIB033, Other: PlaceboOne IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
- Must be a nonsmoker or light smoker (<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
- Must have a body mass index of 18 to 32 kg/m2, inclusive.
Key exclusion criteria (5 listed)
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day -1.
- Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
- History of severe allergic or anaphylactic reactions.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| BIIB033single or multiple dose | Biological | Cohort 1, Cohort 2, Cohort 3 |
| Placebosingle or multiple dose | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to day 113
Number of participants with clinically significant laboratory parameters
Time frame: Up to day 113
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Time frame: Up to day 113
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to day 113
Number of participants with clinically significant neurological examination abnormalities
Time frame: Up to day 113
10 secondary outcomes
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time frame: Up to day 113
PK parameter of BIIB033: AUC over a given dosing interval
Time frame: Up to day 113
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Time frame: Up to day 113
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
Time frame: Up to day 113
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
Time frame: Up to day 113
PK parameter of BIIB033: Volume of distribution at steady state (Vss)
Time frame: Up to day 113
PK parameter of BIIB033: Clearance (CL)
Time frame: Up to day 113
PK parameter of BIIB033: accumulation ratio (RAC)
Time frame: Up to day 113
Number of participants with positive serum BIIB033 antibodies
Time frame: Up to day 113
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 Oct 2016.
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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.
Medical Director study director
Biogen
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 BIIB033 in people with Central Nervous System (CNS) Demyelinating Disease and Multiple Sclerosis, run by Biogen at 1 site in United Kingdom.
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 4 inclusion and 5 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 Oct 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 United Kingdom. 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?
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?
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to day 113). 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 Oct 2016.