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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aducanumab IV | Experimental | Infusion of aducanumab over approximately 1 hour |
|
| aducanumab SC | Experimental | Subcutaneously via injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aducanumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of SC dose of aducanumab: Absolute Bioavailability | 13 weeks | |
| PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) | 13 weeks | |
| PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) | 13 weeks | |
| PK parameter of aducanumab: Maximum observed concentration (Cmax) | 13 weeks | |
| PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax) | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | 13 weeks | |
| Number of participants with clinically significant vital sign abnormalities | 13 weeks | |
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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 |
|---|---|---|---|---|---|---|
| Research Site | Evansville | Indiana | 47710 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000600266 | aducanumab |
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| Number of participants with clinically significant laboratory assessment abnormalities |
| 13 weeks |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | 13 weeks |
| PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast) | 13 weeks |
| PK parameter of aducanumab: Terminal elimination half-life (t1/2) | 13 weeks |
| PK parameter of aducanumab: Volume of distribution (Vd) | 13 weeks |
| PK parameter of aducanumab: Apparent total body clearance (CL/F) | 13 weeks |
| Dallas |
| Texas |
| 75247 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |