Clinical trial NCT04924140: A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers
Official title: A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) Compared to a Single, Weight-Based Intravenous Dose in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2021-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers.

The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2), inclusive.
* Have a negative test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator.
* History of severe allergic, anaphylactic, or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, and diagnostic agents to be administered during the study.
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -1.
* Any immunization or vaccination given within 10 days prior to Day 1 and for 10 days after Day 1.
* Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
* Prior exposure to the study treatment or previous participation in this study or previous studies with aducanumab.
* Mini mental state examination (MMSE) score of \<27 at screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab
timeFrame: Up to Day 85
measure: Maximum Observed Concentration (Cmax) of Aducanumab
timeFrame: Up to Day 85
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments
timeFrame: Up to Day 85
measure: Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
timeFrame: Up to Day 85
measure: Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC
timeFrame: Up to Day 85
measure: Elimination Half-Life (t½) of Aducanumab
timeFrame: Up to Day 85
measure: Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab
timeFrame: Up to Day 85
measure: Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: