Aducanumab
BiologicalAdministered as specified in the treatment arm.
Other names: BIIB037, Aduhelm
NCT Number: NCT05216887
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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Notify Me40 year–70 year
All sexes
Interventional
Phase 1
Anaheim Clinical Trials, Anaheim, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered as specified in the treatment arm.
Other names: BIIB037, Aduhelm
Time frame: Predose and at multiple time points post-dose up to Day 99
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.
Time frame: Up to Day 99
Time frame: Day 1 and Day 99
Time frame: Up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 28
Time frame: Predose and at multiple time points post-dose up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 99
Time frame: Predose and at multiple time points post-dose up to Day 99
Biogen
Industry
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
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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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