Healthy VolunteersPhase 1NCT01407406
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
A Phase 1 study testing BIIB023 - low dose IV Dose and BIIB023 - high dose IV Dose in people with Healthy Volunteers, run by Biogen at 2 sites in 2 countries.
Trial summary
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BIIB023 - low dose IV Dose and BIIB023 - high dose IV Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2011to Feb 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have the ability to understand the purpose and risks of the study \& provide signed \& dated informed consent.
- Chinese, Japanese or Caucasian subjects
- Subjects of childbearing potential must practice effective contraception during the study and 3 months after their last dose of study treatment.
- Must have a BMI within the range of 18.5 to 25 kg/m2.
- Must be willing to abstain from using tobacco and tobacco-containing products during the in-clinic period.
- Must be willing to limit alcohol intake to no more than 2 units per day throughout the duration of the study (with some stricter exceptions at various timepoints).
- Must be deemed healthy as determined by the Investigator, based on assessments at Screening and Day -1.
Who cannot join
- Known to have a positive test result for Human Immunodeficiency Virus (HIV) antibody.
- Known history of hepatitis C or hepatitis B virus.
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test.
- Subjects with a history of carcinoma in situ and malignant disease. (with the exception of basal cell carcinoma that has been completely excised prior to study)
- History of clinically important severe allergic or anaphylactic reactions.
- Known allergy to components of the BIIB023 formulation.
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- History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- Abnormal hematology or blood chemistry values at Screening or Day -1, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Screening.
- History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to screening, and/or a positive urine drug screen (without a medically indicated rationale) or positive alcohol breath test at Screening or on Day -1.
- Active bacterial or viral infection and fever >38°C within 48 hours prior to study treatment administration.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- Surgery within 3 months prior to Day -1 or any surgical procedure planned during the course of the study
- Previous exposure to BIIB023.
- Treatment with another investigational drug , device, or approved therapy for investigational use within 30 days prior to Day -1, or 7 half lives of the investigational product, whichever is longer
- Treatment with any prescription medication within 2 weeks before Day -1 with the exception of oral contraceptives for women of childbearing potential.
- Treatment with any nonprescription medicinal products (including vitamin/mineral/herbal containing preparations but excluding acetaminophen) within the 7 days prior to study treatment.
- Vaccination within 4 weeks of study treatment.
- Blood donation (1 unit or more) within 1 month prior to study treatment or plasma donation within 7 days prior to study treatment.
- Alcohol use within 48 hours prior to study treatment or during the In-Clinic period.
- Current enrollment in any other study treatment or disease study.
- Inability to comply with study requirements.
- Vigorous exercise (as determined by the Investigator) within 72 hours prior to any study visit.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Single-Dose, Randomized, Double-Blind, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.
Read the detailed description
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose, Randomized, Double-Blind, parallel-group study to evaluate the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
- Conditions
- Healthy Volunteers
- Being tested
- BIIB023 - low dose IV Dose, BIIB023 - high dose IV Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB023 - low dose IV DoseDrug
BIIB023 - high dose IV DoseDrug
| Study group | Role | What they receive |
|---|---|---|
| Chinese Subjects - low dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - low dose IV Dose |
| Chinese Subjects - high dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - high dose IV Dose |
| Japanese Subjects - low dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - low dose IV Dose |
| Japanese Subjects - high dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - high dose IV Dose |
| Causasian Subjects - low dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - low dose IV Dose |
| Caucasian Subjects - high dose BIIB023 IV | Experimental | Not described Receives: Drug: BIIB023 - high dose IV Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of BIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Cmax of BIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Tmax of BIIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Half-life of BIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Volume of distribution of BIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Clearance of BIIB023
Measured: Participants will be followed for the duration of a study; an expected 71 days
Secondary outcomes (2)
Number of patients with Adverse Events as a measure of safety and tolerability
Measured: Participants will be followed for the duration of a study; an expected 71 days
Number of patients with Serious Adverse Events as a measure of safety and tolerability
Measured: Participants will be followed for the duration of a study; an expected 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407406
- Sponsor's protocol ID
- 211HV102
- Status last verified
- Mar 2012
- First submitted
- 14 Jul 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Double-Blind, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01407406
- Acronym / sponsor ID
- 211HV102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Aug 2011 (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.
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.
Detailed description
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose, Randomized, Double-Blind, parallel-group study to evaluate the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Chinese Subjects - low dose BIIB023 IV | Experimental | Drug: BIIB023 - low dose IV Dose |
| Chinese Subjects - high dose BIIB023 IV | Experimental | Drug: BIIB023 - high dose IV Dose |
| Japanese Subjects - low dose BIIB023 IV | Experimental | Drug: BIIB023 - low dose IV Dose |
| Japanese Subjects - high dose BIIB023 IV | Experimental | Drug: BIIB023 - high dose IV Dose |
| Causasian Subjects - low dose BIIB023 IV | Experimental | Drug: BIIB023 - low dose IV Dose |
| Caucasian Subjects - high dose BIIB023 IV | Experimental | Drug: BIIB023 - high dose IV Dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must have the ability to understand the purpose and risks of the study \& provide signed \& dated informed consent.
- Chinese, Japanese or Caucasian subjects
- Subjects of childbearing potential must practice effective contraception during the study and 3 months after their last dose of study treatment.
- Must have a BMI within the range of 18.5 to 25 kg/m2.
- Must be willing to abstain from using tobacco and tobacco-containing products during the in-clinic period.
Key exclusion criteria (24 listed)
- Known to have a positive test result for Human Immunodeficiency Virus (HIV) antibody.
- Known history of hepatitis C or hepatitis B virus.
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test.
- Subjects with a history of carcinoma in situ and malignant disease. (with the exception of basal cell carcinoma that has been completely excised prior to study)
- History of clinically important severe allergic or anaphylactic reactions.
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 |
|---|---|---|
| BIIB023 - low dose IV Dose | Drug | Causasian Subjects - low dose BIIB023 IV, Chinese Subjects - low dose BIIB023 IV, Japanese Subjects - low dose BIIB023 IV |
| BIIB023 - high dose IV Dose | Drug | Caucasian Subjects - high dose BIIB023 IV, Chinese Subjects - high dose BIIB023 IV, Japanese Subjects - high dose BIIB023 IV |
Primary outcome
AUC of BIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Cmax of BIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Tmax of BIIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Half-life of BIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Volume of distribution of BIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Clearance of BIIB023
Time frame: Participants will be followed for the duration of a study; an expected 71 days
2 secondary outcomes
Number of patients with Adverse Events as a measure of safety and tolerability
Time frame: Participants will be followed for the duration of a study; an expected 71 days
Number of patients with Serious Adverse Events as a measure of safety and tolerability
Time frame: Participants will be followed for the duration of a study; an expected 71 days
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 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB023 - low dose IV Dose and BIIB023 - high dose IV Dose in people with Healthy Volunteers, run by Biogen at 2 sites in 2 countries.
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 7 inclusion and 24 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, China. 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?
AUC of BIIB023 (time frame: Participants will be followed for the duration of a study; an expected 71 days). 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 16 Sep 2013.