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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216887
• Other study ID #: 221HV104
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: July 27, 2022

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Biological:
• Aducanumab
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	QPS-MRA	Miami	Florida
United States	QPS Missouri	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

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		Predose and at multiple time points post-dose up to Day 99
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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (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 99
Secondary	Number of Participants with Clinically Significant Abnormal Vital Sign Values		Up to Day 99
Secondary	Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values		Day 1 and Day 99
Secondary	Number of Participants with Clinically Significant Abnormal Laboratory Values		Up to Day 99
Secondary	Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Secondary	Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab		Predose and at multiple time points post-dose up to Day 28
Secondary	Maximum Observed Concentration (Cmax) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Secondary	Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC		Predose and at multiple time points post-dose up to Day 99
Secondary	Elimination Half-Life (t1/2) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Secondary	Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab		Predose and at multiple time points post-dose up to Day 99
Secondary	Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab		Predose and at multiple time points post-dose up to Day 99