Clinical trial NCT05216887: A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
Official title: A Randomized, Open-Label, Parallel-Arm Study to Assess the Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 123
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.


Eligibility criteria: Key Inclusion Criteria:

* Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive
* Japanese participant has both biological parents and all 4 grandparents of Japanese descent
* Have a negative polymerase chain reaction 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, any diagnostic agents to be administered during the study
* History of, or positive test result at Screening for, human immunodeficiency virus
* History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
* Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature \> 37.5 degrees Celsius \[°C\]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
* 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
* Any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment
* Mini mental state examination 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: Predose and at multiple time points post-dose up to Day 99
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 99
measure: Number of Participants with Clinically Significant Abnormal Vital Sign Values
timeFrame: Up to Day 99
measure: Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values
timeFrame: Day 1 and Day 99
measure: Number of Participants with Clinically Significant Abnormal Laboratory Values
timeFrame: Up to Day 99
measure: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 99
measure: Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 28
measure: Maximum Observed Concentration (Cmax) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 99
measure: Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC
timeFrame: Predose and at multiple time points post-dose up to Day 99
measure: Elimination Half-Life (t1/2) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 99
measure: Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 99
measure: Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
timeFrame: Predose and at multiple time points post-dose up to Day 99
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Miami
country: United States
facility: QPS-MRA
state: Florida
city: Springfield
country: United States
facility: QPS Missouri
state: Missouri
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: