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Completed

NCT Number: NCT02782975

Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Evansville, Indiana, 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:

  • A minimum weight of 45 kg, inclusive, at Day -1.
  • All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
  • Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.

Key Exclusion Criteria:

  • Mini mental state examination (MMSE) score of <27 at Screening.
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
  • History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
  • History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
  • History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
  • Positive test result at Screening for hepatitis C virus antibody (HCVAb).
  • Positive test result at Screening for hepatitis B virus (defined as positive for both, hepatitis B surface antigen [HBsAg] AND hepatitis B core antibody [HBcAb]).
  • Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 90 days prior to Day -1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

aducanumab

Drug

Other names: BIIB037

Primary outcomes

  1. PK parameter of SC dose of aducanumab: Absolute Bioavailability

    Time frame: 13 weeks

  2. PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: 13 weeks

  3. PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: 13 weeks

  4. PK parameter of aducanumab: Maximum observed concentration (Cmax)

    Time frame: 13 weeks

  5. PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)

    Time frame: 13 weeks

Secondary outcomes

  1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 13 weeks

  2. Number of participants with clinically significant vital sign abnormalities

    Time frame: 13 weeks

  3. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: 13 weeks

  4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: 13 weeks

  5. PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)

    Time frame: 13 weeks

  6. PK parameter of aducanumab: Terminal elimination half-life (t1/2)

    Time frame: 13 weeks

  7. PK parameter of aducanumab: Volume of distribution (Vd)

    Time frame: 13 weeks

  8. PK parameter of aducanumab: Apparent total body clearance (CL/F)

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 26, 2016
Registry last updated
Jan 13, 2017

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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