Alzheimer's DiseasePhase 1NCT02782975
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
A Phase 1 study testing aducanumab in people with Alzheimer's Disease, run by Biogen at 2 sites in United States.
Trial summary
The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- aducanumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Nov 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A minimum weight of 45 kg, inclusive, at Day -1.
- All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
- Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.
Who cannot join
- Mini mental state examination (MMSE) score of <27 at Screening.
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Positive test result at Screening for hepatitis C virus antibody (HCVAb).
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- Positive test result at Screening for hepatitis B virus (defined as positive for both, hepatitis B surface antigen [HBsAg] AND hepatitis B core antibody [HBcAb]).
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 90 days prior to Day -1.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Dallas, Texas, 75247
Research Site
Evansville, Indiana, 47710
About this study
Official title: A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose
The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.
- Conditions
- Alzheimer's Disease
- Being tested
- aducanumab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aducanumabDrug
Also called BIIB037
| Study group | Role | What they receive |
|---|---|---|
| aducanumab IV | Experimental | Infusion of aducanumab over approximately 1 hour Receives: Drug: aducanumab |
| aducanumab SC | Experimental | Subcutaneously via injection Receives: Drug: aducanumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter of SC dose of aducanumab: Absolute Bioavailability
Measured: 13 weeks
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Measured: 13 weeks
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Measured: 13 weeks
PK parameter of aducanumab: Maximum observed concentration (Cmax)
Measured: 13 weeks
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Measured: 13 weeks
Secondary outcomes (8)
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 13 weeks
Number of participants with clinically significant vital sign abnormalities
Measured: 13 weeks
Number of participants with clinically significant laboratory assessment abnormalities
Measured: 13 weeks
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: 13 weeks
PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Measured: 13 weeks
PK parameter of aducanumab: Terminal elimination half-life (t1/2)
Measured: 13 weeks
PK parameter of aducanumab: Volume of distribution (Vd)
Measured: 13 weeks
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- None (open label)
- Enrolment
- 28 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
- NCT02782975
- Sponsor's protocol ID
- 221HV102
- Status last verified
- Jan 2017
- First submitted
- 23 May 2016
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose
- ClinicalTrials.gov ID
- NCT02782975
- Acronym / sponsor ID
- 221HV102
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 May 2016 (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 objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aducanumab IV | Experimental | Drug: aducanumabInfusion of aducanumab over approximately 1 hour |
| aducanumab SC | Experimental | Drug: aducanumabSubcutaneously via injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A minimum weight of 45 kg, inclusive, at Day -1.
- All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
- Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.
Key exclusion criteria (9 listed)
- Mini mental state examination (MMSE) score of <27 at Screening.
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
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 |
|---|---|---|
| aducanumabAlso: BIIB037 | Drug | aducanumab IV, aducanumab SC |
Primary outcome
PK parameter of SC dose of aducanumab: Absolute Bioavailability
Time frame: 13 weeks
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 13 weeks
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 13 weeks
PK parameter of aducanumab: Maximum observed concentration (Cmax)
Time frame: 13 weeks
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Time frame: 13 weeks
8 secondary outcomes
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 13 weeks
Number of participants with clinically significant vital sign abnormalities
Time frame: 13 weeks
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: 13 weeks
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: 13 weeks
PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time frame: 13 weeks
PK parameter of aducanumab: Terminal elimination half-life (t1/2)
Time frame: 13 weeks
PK parameter of aducanumab: Volume of distribution (Vd)
Time frame: 13 weeks
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Time frame: 13 weeks
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 13 Jan 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aducanumab in people with Alzheimer's Disease, run by Biogen at 2 sites 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 3 inclusion and 9 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 13 Jan 2017. 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 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?
PK parameter of SC dose of aducanumab: Absolute Bioavailability (time frame: 13 weeks). The study lists 5 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 13 Jan 2017.