Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: aducanumab IV Infusion of aducanumab over approximately 1 hour |
Drug: aducanumab
Other Names:
|
| Experimental: aducanumab SC Subcutaneously via injection |
Drug: aducanumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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A minimum weight of 45 kg, inclusive, at Day -1.
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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).
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Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.
Key Exclusion Criteria:
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Mini mental state examination (MMSE) score of <27 at Screening.
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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.
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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.
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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).
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History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
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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]).
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Evansville | Indiana | United States | 47710 |
| 2 | Research Site | Dallas | Texas | United States | 75247 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 221HV102