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

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782975
• Other study ID #: 221HV102
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2016
• Last updated: January 12, 2017
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• aducanumab

Locations

Country	Name	City	State
United States	Research Site	Dallas	Texas
United States	Research Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter of SC dose of aducanumab: Absolute Bioavailability		13 weeks
Primary	PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)		13 weeks
Primary	PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)		13 weeks
Primary	PK parameter of aducanumab: Maximum observed concentration (Cmax)		13 weeks
Primary	PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)		13 weeks
Secondary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		13 weeks
Secondary	Number of participants with clinically significant vital sign abnormalities		13 weeks
Secondary	Number of participants with clinically significant laboratory assessment abnormalities		13 weeks
Secondary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		13 weeks
Secondary	PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)		13 weeks
Secondary	PK parameter of aducanumab: Terminal elimination half-life (t1/2)		13 weeks
Secondary	PK parameter of aducanumab: Volume of distribution (Vd)		13 weeks
Secondary	PK parameter of aducanumab: Apparent total body clearance (CL/F)		13 weeks