A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

Healthy Volunteers 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) Compared to a Single, Weight-Based Intravenous Dose in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924140
• Other study ID #: 221HV103
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Aducanumab
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Eisai Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab		Up to Day 85
Primary	Maximum Observed Concentration (Cmax) of Aducanumab		Up to Day 85
Secondary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Signs		Up to Day 85
Secondary	Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)		Up to Day 85
Secondary	Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments		Up to Day 85
Secondary	Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab		Up to Day 85
Secondary	Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC		Up to Day 85
Secondary	Elimination Half-Life (t½) of Aducanumab		Up to Day 85
Secondary	Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab		Up to Day 85
Secondary	Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab		Up to Day 85