> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-pharmacokinetic-pk-comparability-of-2-cf381787-5eeb-4f18-8793-9b600bea90f5 > Record changed: 2026-11-04 # 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 NCT05216887 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Participants 123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Lead sponsor Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Start date 2022-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Dates **Completion date** 2022-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **First posted** 2022-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Registry last updated** 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Primary completion date** 2022-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Start date** 2022-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Size and sites **Actual participants** 123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Participants** 123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Lead sponsor** Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Identifiers **Registry ID** NCT05216887 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **ClinicalTrials.gov ID** NCT05216887 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Outcomes ### Primary outcomes 1. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab Timeframe: 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) Timeframe: 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 Timeframe: Up to Day 99 3. Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values Timeframe: Day 1 and Day 99 4. Number of Participants with Clinically Significant Abnormal Laboratory Values Timeframe: Up to Day 99 5. Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab Timeframe: 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 Timeframe: Predose and at multiple time points post-dose up to Day 28 7. Maximum Observed Concentration (Cmax) of Aducanumab Timeframe: Predose and at multiple time points post-dose up to Day 99 8. Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC Timeframe: Predose and at multiple time points post-dose up to Day 99 9. Elimination Half-Life (t1/2) of Aducanumab Timeframe: 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 Timeframe: Predose and at multiple time points post-dose up to Day 99 11. Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab Timeframe: Predose and at multiple time points post-dose up to Day 99 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 70 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Sites - Anaheim Clinical TrialsAnaheim, United States - QPS-MRAMiami, United States - QPS MissouriSpringfield, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05216887) ## Related records ### Drugs (1) - [Aducanumab](https://trialight.com/data/asset/aducanumab-d7f09a77-3bba-47ee-b5c6-b358810893be.md) ### Lead sponsors (1) - [Biogen](https://trialight.com/data/company/biogen-f4a36ded-071a-4089-ac47-d219e9d21c44.md) ### Targets (1) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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