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

• ClinicalTrials.gov Identifier: NCT02782975
• Recruitment Status: Completed
• First Posted: May 26, 2016
• Last Update Posted: January 13, 2017
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

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
Alzheimer's Disease	Drug: aducanumab	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: May 2016
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: aducanumab IV; Infusion of aducanumab over approximately 1 hour	Drug: aducanumab; Other Name: BIIB037
Experimental: aducanumab SC; Subcutaneously via injection	Drug: aducanumab; Other Name: BIIB037

Outcome Measures

Primary Outcome Measures :

1. PK parameter of SC dose of aducanumab: Absolute Bioavailability [ Time Frame: 13 weeks ]
2. PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 13 weeks ]
3. PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 13 weeks ]
4. PK parameter of aducanumab: Maximum observed concentration (Cmax) [ Time Frame: 13 weeks ]
5. PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax) [ Time Frame: 13 weeks ]

Secondary Outcome Measures :

1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 13 weeks ]
2. Number of participants with clinically significant vital sign abnormalities [ Time Frame: 13 weeks ]
3. Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: 13 weeks ]
4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: 13 weeks ]
5. 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 ]
6. PK parameter of aducanumab: Terminal elimination half-life (t1/2) [ Time Frame: 13 weeks ]
7. PK parameter of aducanumab: Volume of distribution (Vd) [ Time Frame: 13 weeks ]
8. PK parameter of aducanumab: Apparent total body clearance (CL/F) [ Time Frame: 13 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Research Site

Evansville, Indiana, United States, 47710

United States, Texas

Research Site

Dallas, Texas, United States, 75247

Sponsors and Collaborators

Biogen

Investigators

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT02782975
• Other Study ID Numbers: 221HV102
• First Posted: May 26, 2016
• Last Update Posted: January 13, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders