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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aducanumab IV | Active Comparator | Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1. |
|
| Aducanumab SC | Experimental | Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aducanumab | Biological | Administered as specified in the treatment arm. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| QPS-MRA |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Up to Day 99 |
| 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 |
| Maximum Observed Concentration (Cmax) of Aducanumab | Predose and at multiple time points post-dose up to Day 99 |
| 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 |
| Miami |
| Florida |
| 33143 |
| United States |
| QPS Missouri | Springfield | Missouri | 65802 | United States |
| ID | Term |
|---|---|
| C000600266 | aducanumab |
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