Healthy VolunteerPhase 1NCT05216887
A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
A Phase 1 study testing Aducanumab in people with Healthy Volunteer, run by Biogen at 3 sites in United States.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- 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
- 123 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2022to 27 Jul 2022
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index between 18 and 30 kilograms per meter square (kg/m^2), inclusive
- Japanese participant has both biological parents and all 4 grandparents of Japanese descent
- Have a negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1
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 of severe allergic, anaphylactic or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study
- History of, or positive test result at Screening for, human immunodeficiency virus
- History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
- Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degrees Celsius [°C]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
- Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer
Show all 9Show fewer
- Any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment
- Mini mental state examination score of < 27 at Screening
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anaheim Clinical Trials
Anaheim, California, 92801
QPS-MRA
Miami, Florida, 33143
QPS Missouri
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Open-Label, Parallel-Arm Study to Assess the Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.
- Conditions
- Healthy Volunteer
- Being tested
- Aducanumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AducanumabBiological
Also called BIIB037, Aduhelm
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Aducanumab IV | Active comparator | Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1. Receives: Biological: Aducanumab |
| Aducanumab SC | Experimental | Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15. Receives: Biological: Aducanumab |
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) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Secondary outcomes (11)
Number 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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Measured: Up to Day 99
Number of Participants with Clinically Significant Abnormal Vital Sign Values
Measured: Up to Day 99
Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values
Measured: Day 1 and Day 99
Number of Participants with Clinically Significant Abnormal Laboratory Values
Measured: Up to Day 99
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 28
Maximum Observed Concentration (Cmax) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC
Measured: Predose and at multiple time points post-dose up to Day 99
Elimination Half-Life (t1/2) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
Measured: Predose and at multiple time points post-dose up to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Feb 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- None (open label)
- Enrolment
- 123 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
- NCT05216887
- Sponsor's protocol ID
- 221HV104
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. 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 Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05216887
- Acronym / sponsor ID
- 221HV104
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 1 Feb 2022 (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.
The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aducanumab IV | Active comparator | Biological: AducanumabParticipants will receive a single weight-based dose of aducanumab via IV infusion on Day 1. |
| Aducanumab SC | Experimental | Biological: AducanumabParticipants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a body mass index between 18 and 30 kilograms per meter square (kg/m^2), inclusive
- Japanese participant has both biological parents and all 4 grandparents of Japanese descent
- Have a negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1
Key exclusion criteria (9 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 of severe allergic, anaphylactic or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study
- History of, or positive test result at Screening for, human immunodeficiency virus
- History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
- Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degrees Celsius [°C]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
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, AduhelmAdministered as specified in the treatment arm. | Biological | Aducanumab IV, Aducanumab SC |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
11 secondary outcomes
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 99
Number of Participants with Clinically Significant Abnormal Vital Sign Values
Time frame: Up to Day 99
Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values
Time frame: Day 1 and Day 99
Number of Participants with Clinically Significant Abnormal Laboratory Values
Time frame: Up to Day 99
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 28
Maximum Observed Concentration (Cmax) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC
Time frame: Predose and at multiple time points post-dose up to Day 99
Elimination Half-Life (t1/2) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
Time frame: Predose and at multiple time points post-dose up to Day 99
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 18 Apr 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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
3 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 Healthy Volunteer, run by Biogen at 3 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab (time frame: Predose and at multiple time points post-dose up to Day 99). 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 18 Apr 2023.