Healthy Volunteer
Conditions
Brief 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. 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.
Interventions
BIOLOGICALAducanumab
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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
* 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 * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab | Predose and at multiple time points post-dose up to Day 99 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinically Significant Abnormal Vital Sign Values | Up to Day 99 | — |
| Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values | Day 1 and Day 99 | — |
| Number of Participants with Clinically Significant Abnormal Laboratory Values | Up to Day 99 | — |
| Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab | 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 | Predose and at multiple time points post-dose up to Day 28 | — |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 99 | 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. |
| Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC | Predose and at multiple time points post-dose up to Day 99 | — |
| Elimination Half-Life (t1/2) of Aducanumab | 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 | Predose and at multiple time points post-dose up to Day 99 | — |
| Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab | Predose and at multiple time points post-dose up to Day 99 | — |
| Maximum Observed Concentration (Cmax) of Aducanumab | Predose and at multiple time points post-dose up to Day 99 | — |
Countries
United States
Outcome results
None listed