HealthyPhase 1NCT01929746
Daclizumab Japanese PK Study
A Phase 1 study testing BIIB019 subcutaneous injection in people with Healthy, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB019 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years or significantly modified their diets since leaving Japan.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 4 months after their last dose of study treatment.
- Body mass index (BMI) within 18 to 30 kg/m2, inclusive.
- Nonsmoker 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 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
- History of a positive test result for human immunodeficiency virus (HIV) antibody.
- History of hepatitis or a positive test result for hepatitis C virus antibody (HCVAb) or hepatitis B virus antibody (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation.
- 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, are not eligible.
- 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.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Single-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB019, Daclizumab High Yield Process (DAC HYP), in Japanese and Caucasian Adult Healthy Volunteers
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).
- Conditions
- Healthy
- Being tested
- BIIB019 subcutaneous injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB019 subcutaneous injectionBiological
Also called Daclizumab High Yield Process, DAC HYP
participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
| Study group | Role | What they receive |
|---|---|---|
| BIIB019, 75 mg | Experimental | BIIB019 delivered via Subcutaneous Injection Receives: Biological: BIIB019 subcutaneous injection |
| BIIB019, 150 mg | Experimental | BIIB019 delivered via Subcutaneous Injection Receives: Biological: BIIB019 subcutaneous injection |
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 0 to infinity (AUCinf)
Measured: Up to Day 105
Maximum observed concentration (Cmax)
Measured: Up to Day 105
Time to reach maximum observed concentration (Tmax)
Measured: Up to Day 105
Terminal elimination half-life (t1/2)
Measured: Up to Day 105
Apparent volume of distribution (Vd/F)
Measured: Up to Day 105
Apparent clearance (CL/F)
Measured: Up to Day 105
Secondary outcomes (1)
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929746
- Sponsor's protocol ID
- 205HV102
- Other IDs
- EUDRA CT NO: 2013-002310-12
- Status last verified
- May 2014
- First submitted
- 23 Aug 2013
- Last updated
- 2 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Single-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB019, Daclizumab High Yield Process (DAC HYP), in Japanese and Caucasian Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01929746
- Acronym / sponsor ID
- 205HV102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Aug 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 the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB019, 75 mg | Experimental | Biological: BIIB019 subcutaneous injectionBIIB019 delivered via Subcutaneous Injection |
| BIIB019, 150 mg | Experimental | Biological: BIIB019 subcutaneous injectionBIIB019 delivered via Subcutaneous Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years or significantly modified their diets since leaving Japan.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 4 months after their last dose of study treatment.
- Body mass index (BMI) within 18 to 30 kg/m2, inclusive.
- Nonsmoker 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 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 (7 listed)
- History of a positive test result for human immunodeficiency virus (HIV) antibody.
- History of hepatitis or a positive test result for hepatitis C virus antibody (HCVAb) or hepatitis B virus antibody (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation.
- 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, are not eligible.
- Treatment with any prescription medication within 2 weeks before Day -1 with the exception of oral contraceptives for women of childbearing potential.
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 |
|---|---|---|
| BIIB019 subcutaneous injectionAlso: Daclizumab High Yield Process, DAC HYPparticipants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group | Biological | BIIB019, 150 mg, BIIB019, 75 mg |
Primary outcome
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to Day 105
Maximum observed concentration (Cmax)
Time frame: Up to Day 105
Time to reach maximum observed concentration (Tmax)
Time frame: Up to Day 105
Terminal elimination half-life (t1/2)
Time frame: Up to Day 105
Apparent volume of distribution (Vd/F)
Time frame: Up to Day 105
Apparent clearance (CL/F)
Time frame: Up to Day 105
1 secondary outcome
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 105
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 2 May 2014.
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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 BIIB019 subcutaneous injection 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 7 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 2 May 2014. 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 0 to infinity (AUCinf) (time frame: Up to Day 105). 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 2 May 2014.