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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aducanumab

Biological

Administered as specified in the treatment arm.

Other names: BIIB037, Aduhelm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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