Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: aducanumab

• Registration Number: NCT02782975
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• A minimum weight of 45 kg, inclusive, at Day -1.
• 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).
• Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.

Key

Exclusion Criteria

• Mini mental state examination (MMSE) score of <27 at Screening.
• 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.
• 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.
• 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).
• History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
• Positive test result at Screening for hepatitis C virus antibody (HCVAb).
• 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]).
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aducanumab IV	aducanumab	Infusion of aducanumab over approximately 1 hour
aducanumab SC	aducanumab	Subcutaneously via injection

Primary Outcome Measures

Name	Time	Method
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 dose of aducanumab: Absolute Bioavailability	13 weeks
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)	13 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States