Clinical trial NCT02782975: Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: PK parameter of SC dose of aducanumab: Absolute Bioavailability
timeFrame: 13 weeks
measure: PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: 13 weeks
measure: PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: 13 weeks
measure: PK parameter of aducanumab: Maximum observed concentration (Cmax)
timeFrame: 13 weeks
measure: PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
timeFrame: 13 weeks
Secondary outcomes:
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 13 weeks
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: 13 weeks
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: 13 weeks
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: 13 weeks
measure: PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
timeFrame: 13 weeks
measure: PK parameter of aducanumab: Terminal elimination half-life (t1/2)
timeFrame: 13 weeks
measure: PK parameter of aducanumab: Volume of distribution (Vd)
timeFrame: 13 weeks
measure: PK parameter of aducanumab: Apparent total body clearance (CL/F)
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Dallas
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: