The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered as specified in the treatment arm
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Qps-Mra, Llc
South Miami, Florida, United States
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab
Time frame: Up to Day 85
Maximum Observed Concentration (Cmax) of Aducanumab
Time frame: Up to Day 85
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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An 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 frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
Time frame: Up to Day 85
Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments
Time frame: Up to Day 85
Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
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Time frame: Up to Day 85
Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC
Time frame: Up to Day 85
Elimination Half-Life (t½) of Aducanumab
Time frame: Up to Day 85
Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab
Time frame: Up to Day 85
Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
Time frame: Up to Day 85