HealthyPhase 1NCT01978652
Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.
A Phase 1 study testing Peginterferon Beta-1a in people with Healthy, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Peginterferon Beta-1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Feb 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a BMI of 19 to 29 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and at Baseline.
- Japanese subjects must have been born in Japan and have both parents and grandparents of Japanese origin. Additionally, Japanese subjects should have lived outside of Japan for less than 5 years and maintained a similar diet since leaving Japan (to be verified by a questionnaire at Screening).
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment.
- Non smoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes (or equivalent) per day throughout the remainder of the study.
- Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.
Who cannot join
- Known history of, or positive test result at Screening for human immunodeficiency virus (HIV).
- Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg]).
- Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured or subjects with cervical cancer stage 0 if completely excised).
- History of severe allergic or anaphylactic reactions in the opinion of the Investigator.
- Known allergy to any interferon or any component of BIIB017.
- History of suicidal ideation or an episode of clinically significant depression (as determined by the Investigator) within 3 months prior to Day 1.
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- Any previous treatment with prescription or investigational pegylated drugs. The prior use of over-the-counter pegylated products, including cosmetics, is allowed.
- Previous treatment with any interferon product.
- History of hypersensitivity or intolerance to paracetamol, ibuprofen, or naproxen, that would preclude use of at least 1 of these during the study.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Arm, Open-Label, Single-Dose, Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) in Japanese and Caucasian Adult Healthy Subjects
The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.
- Conditions
- Healthy
- Being tested
- Peginterferon Beta-1a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Beta-1aBiological
Also called Plegridy, BIIB017
As specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Beta-1a administered to Japanese participants | Experimental | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe Receives: Biological: Peginterferon Beta-1a |
| Peginterferon Beta-1a administered to Caucasian participants | Experimental | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe Receives: Biological: Peginterferon Beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
Measured: Up to 240 hours post-dose
Secondary outcomes (2)
Maximum observed serum concentration (Cmax) of Peginterferon Beta-1a
Measured: Up to 240 hours post-dose
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT01978652
- Sponsor's protocol ID
- 105HV104
- Other IDs
- 2013-002912-28
- Status last verified
- Jan 2015
- First submitted
- 1 Nov 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm, Open-Label, Single-Dose, Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) in Japanese and Caucasian Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT01978652
- Acronym / sponsor ID
- 105HV104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Nov 2013 (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 characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Beta-1a administered to Japanese participants | Experimental | Biological: Peginterferon Beta-1aA single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
| Peginterferon Beta-1a administered to Caucasian participants | Experimental | Biological: Peginterferon Beta-1aA single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have a BMI of 19 to 29 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and at Baseline.
- Japanese subjects must have been born in Japan and have both parents and grandparents of Japanese origin. Additionally, Japanese subjects should have lived outside of Japan for less than 5 years and maintained a similar diet since leaving Japan (to be verified by a questionnaire at Screening).
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment.
- Non smoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes (or equivalent) per day throughout the remainder of the study.
- Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.
Key exclusion criteria (10 listed)
- Known history of, or positive test result at Screening for human immunodeficiency virus (HIV).
- Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg]).
- Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured or subjects with cervical cancer stage 0 if completely excised).
- History of severe allergic or anaphylactic reactions in the opinion of the Investigator.
- Known allergy to any interferon or any component of BIIB017.
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 |
|---|---|---|
| Peginterferon Beta-1aAlso: Plegridy, BIIB017As specified in the treatment arm | Biological | Peginterferon Beta-1a administered to Caucasian participants, Peginterferon Beta-1a administered to Japanese participants |
Primary outcome
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: Up to 240 hours post-dose
2 secondary outcomes
Maximum observed serum concentration (Cmax) of Peginterferon Beta-1a
Time frame: Up to 240 hours post-dose
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 29
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 9 Jan 2015.
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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 Peginterferon Beta-1a in people with Healthy, 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 5 inclusion and 10 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 9 Jan 2015. 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?
Area under the concentration-time curve from time zero to infinity (AUC0-∞) (time frame: Up to 240 hours post-dose). 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 9 Jan 2015.