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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Research Site
Evansville, Indiana, United States
Research Site
Dallas, Texas, United States
PK parameter of SC dose of aducanumab: Absolute Bioavailability
Time frame: 13 weeks
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 13 weeks
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 13 weeks
PK parameter of aducanumab: Maximum observed concentration (Cmax)
Time frame: 13 weeks
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
Time frame: 13 weeks
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 13 weeks
Number of participants with clinically significant vital sign abnormalities
Time frame: 13 weeks
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: 13 weeks
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: 13 weeks
PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time frame: 13 weeks
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PK parameter of aducanumab: Terminal elimination half-life (t1/2)
Time frame: 13 weeks
PK parameter of aducanumab: Volume of distribution (Vd)
Time frame: 13 weeks
PK parameter of aducanumab: Apparent total body clearance (CL/F)
Time frame: 13 weeks