[Information provided by:
ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]
|NCT02782975 : Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants|
|Ages||Min: 18 Years Max: 55 Years|
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
- 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
- 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
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02782975
| Link to official Clinicaltrials.gov listing