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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

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ClinicalTrials.gov Identifier: NCT05216887
Recruitment Status : Completed
First Posted : February 1, 2022
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Biological: Aducanumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2022
Actual Primary Completion Date : July 27, 2022
Actual Study Completion Date : July 27, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aducanumab

Arm Intervention/treatment
Active Comparator: Aducanumab IV
Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1.
Biological: Aducanumab
Administered as specified in the treatment arm.
Other Names:
  • BIIB037
  • Aduhelm

Experimental: Aducanumab SC
Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15.
Biological: Aducanumab
Administered as specified in the treatment arm.
Other Names:
  • BIIB037
  • Aduhelm




Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 99 ]
    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.

  2. Number of Participants with Clinically Significant Abnormal Vital Sign Values [ Time Frame: Up to Day 99 ]
  3. Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values [ Time Frame: Day 1 and Day 99 ]
  4. Number of Participants with Clinically Significant Abnormal Laboratory Values [ Time Frame: Up to Day 99 ]
  5. Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]
  6. Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 28 ]
  7. Maximum Observed Concentration (Cmax) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]
  8. Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]
  9. Elimination Half-Life (t1/2) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]
  10. Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]
  11. Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab [ Time Frame: Predose and at multiple time points post-dose up to Day 99 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216887


Locations
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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
United States, Florida
QPS-MRA
Miami, Florida, United States, 33143
United States, Missouri
QPS Missouri
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT05216887    
Other Study ID Numbers: 221HV104
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No