NCT02782975

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

May 23, 2016

Last Update Submit

January 12, 2017

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (5)

  • PK parameter of SC dose of aducanumab: Absolute Bioavailability

    13 weeks

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

    13 weeks

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

    13 weeks

  • PK parameter of aducanumab: Maximum observed concentration (Cmax)

    13 weeks

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

    13 weeks

Secondary Outcomes (8)

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

    13 weeks

  • Number of participants with clinically significant vital sign abnormalities

    13 weeks

  • Number of participants with clinically significant laboratory assessment abnormalities

    13 weeks

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

    13 weeks

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

    13 weeks

  • +3 more secondary outcomes

Study Arms (2)

aducanumab IV

EXPERIMENTAL

Infusion of aducanumab over approximately 1 hour

Drug: aducanumab

aducanumab SC

EXPERIMENTAL

Subcutaneously via injection

Drug: aducanumab

Interventions

aducanumabDRUG
Also known as: BIIB037
aducanumab IVaducanumab SC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Evansville, Indiana, 47710, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

aducanumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 26, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(2)