Healthy SubjectsPhase 1NCT03224793
Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.
A Phase 1 study testing BIIB059 in people with Healthy Subjects, run by Biogen at 1 site in United States.
Trial summary
To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- BIIB059
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 12 Jun 2018
- 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
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
- Must have been born in Japan, and both their biological parents and grandparents must have been of Japanese origin
- Aged 18 to 55 years old, inclusive, at the time of informed consent, and must have a body mass index between 18 and 30 kilogram per square meter (kg/m2), and a body weight >45 kg
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 16 weeks after their dose of study treatment
Who cannot join
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
- History or positive test result for human immunodeficiency virus. Current active hepatitis C virus infection (defined as hepatitis C virus RNA above the limit of detection). Positive test result for hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody). Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 5 half-lives prior to Day -1
- History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug or alcohol test at Screening or Day -1, an unwillingness to refrain from illicit or recreational drugs, or an unwillingness to abide by the alcohol restrictions
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Cypress, California, 90630
About this study
Official title: A Blinded, Safety, Tolerability, and Pharmacokinetic Study of Single Doses of BIIB059 in Healthy Japanese Subjects
To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects.
- Conditions
- Healthy Subjects
- Being tested
- BIIB059, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB059Drug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| BIIB059 20 mg | Experimental | Participants will receive single subcutaneous (SC) dose of 20 milligram (mg) BIIB059 or matching placebo on Day 1. Receives: Drug: BIIB059; Drug: Placebo |
| BIIB059 50mg | Experimental | Participants will receive single SC dose of 50 mg BIIB059 or matching placebo on Day 1. Receives: Drug: BIIB059; Drug: Placebo |
| BIIB059 150mg | Experimental | Participants will receive single SC dose of 150 mg BIIB059 or matching placebo on Day 1. Receives: Drug: BIIB059; Drug: Placebo |
| BIIB059 450mg | Experimental | Participants will receive single SC dose of 450 mg BIIB059 or matching placebo on Day 1. Receives: Drug: BIIB059; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose: results in death; life-threatening event; requires inpatient hospitalization; significant disability; congenital anomaly; medically important event.
Measured: Up to 20 weeks
Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings
Measured: Up to 20 weeks
Percentage of Participants With Anti-BIIB059 Antibodies
Measured: Up to 20 weeks
Secondary outcomes (9)
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Measured: Up to 28 days
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Measured: Up to 112 days
Maximum Observed Concentration (Cmax)
Measured: Up to 112 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),
Measured: Up to 112 days
Time to Reach Maximum Observed Concentration (Tmax)
Measured: Up to 112 days
Terminal Half-Life (t1/2)
Measured: Up to 112 days
Time of Last Measurable Concentration (Tlast)
Measured: Up to 112 days
Apparent Total Clearance (CL/F)
Measured: Up to 112 days
Apparent Volume of Distribution (Vz/F)
Measured: Up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start4 Oct 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT03224793
- Sponsor's protocol ID
- 230HV101
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Safety, Tolerability, and Pharmacokinetic Study of Single Doses of BIIB059 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03224793
- Acronym / sponsor ID
- 230HV101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIIB059 20 mg | Experimental | Drug: BIIB059, Drug: PlaceboParticipants will receive single subcutaneous (SC) dose of 20 milligram (mg) BIIB059 or matching placebo on Day 1. |
| BIIB059 50mg | Experimental | Drug: BIIB059, Drug: PlaceboParticipants will receive single SC dose of 50 mg BIIB059 or matching placebo on Day 1. |
| BIIB059 150mg | Experimental | Drug: BIIB059, Drug: PlaceboParticipants will receive single SC dose of 150 mg BIIB059 or matching placebo on Day 1. |
| BIIB059 450mg | Experimental | Drug: BIIB059, Drug: PlaceboParticipants will receive single SC dose of 450 mg BIIB059 or matching placebo on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
- Must have been born in Japan, and both their biological parents and grandparents must have been of Japanese origin
- Aged 18 to 55 years old, inclusive, at the time of informed consent, and must have a body mass index between 18 and 30 kilogram per square meter (kg/m2), and a body weight >45 kg
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 16 weeks after their dose of study treatment
Key exclusion criteria (6 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
- History or positive test result for human immunodeficiency virus. Current active hepatitis C virus infection (defined as hepatitis C virus RNA above the limit of detection). Positive test result for hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody). Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 5 half-lives prior to Day -1
- History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug or alcohol test at Screening or Day -1, an unwillingness to refrain from illicit or recreational drugs, or an unwillingness to abide by the alcohol restrictions
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 |
|---|---|---|
| BIIB059Administered as specified in the treatment arm | Drug | BIIB059 150mg, BIIB059 20 mg, BIIB059 450mg, BIIB059 50mg |
| PlaceboAdministered as specified in the treatment arm | Drug | BIIB059 150mg, BIIB059 20 mg, BIIB059 450mg, BIIB059 50mg |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 20 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose: results in death; life-threatening event; requires inpatient hospitalization; significant disability; congenital anomaly; medically important event.
Percentage of Participants With Clinically Significant Abnormal Clinical Laboratory Parameters, Vital Signs, 12-Lead Electrocardiograms (ECG), and Physical Examination Findings
Time frame: Up to 20 weeks
Percentage of Participants With Anti-BIIB059 Antibodies
Time frame: Up to 20 weeks
9 secondary outcomes
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Time frame: Up to 28 days
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: Up to 112 days
Maximum Observed Concentration (Cmax)
Time frame: Up to 112 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf),
Time frame: Up to 112 days
Time to Reach Maximum Observed Concentration (Tmax)
Time frame: Up to 112 days
Terminal Half-Life (t1/2)
Time frame: Up to 112 days
Time of Last Measurable Concentration (Tlast)
Time frame: Up to 112 days
Apparent Total Clearance (CL/F)
Time frame: Up to 112 days
Apparent Volume of Distribution (Vz/F)
Time frame: Up to 112 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 31 Aug 2018.
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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 BIIB059 in people with Healthy Subjects, run by Biogen at 1 site in United States.
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 6 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 31 Aug 2018. 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 States. 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?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 20 weeks). 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?
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 31 Aug 2018.