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Monoclonal Antibodies

Aducanumab SC for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 99
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 99
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 99 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab
Secondary outcome measures
Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab
Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab
+8 more

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922
21%
Amyloid related imaging abnormality-oedema/effusion
14%
Covid-19
14%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
8%
Headache
7%
Infusion related reaction
4%
Arthralgia
4%
Dizziness
3%
Pneumonia
3%
Nasopharyngitis
3%
Constipation
3%
Vertigo
3%
Anxiety
3%
Upper respiratory tract infection
3%
Dyspnoea
1%
Hypertonic bladder
1%
Pericardial effusion
1%
Urinary tract infection
1%
Infusion site reaction
1%
Macular hole
1%
Tooth infection
1%
Affective disorder
1%
Pneumothorax
1%
Ingrowing nail
1%
Mental status changes
1%
Nephrolithiasis
1%
Chest pain
1%
Feeling abnormal
1%
Food poisoning
1%
Gastritis
1%
Aspartate aminotransferase increased
1%
Deep vein thrombosis
1%
Skin laceration
1%
Meniere's disease
1%
Hypersensitivity
1%
Pain in extremity
1%
Pulmonary embolism
1%
Diverticulitis
1%
Rib fracture
1%
Gastrooesophageal reflux disease
1%
Insomnia
1%
Sinusitis
1%
Tooth abscess
1%
Campylobacter infection
1%
Ear infection
1%
Dry skin
1%
Knee arthroplasty
1%
Diarrhoea
1%
Oedema peripheral
1%
Nausea
1%
Alanine aminotransferase increased
1%
Hypotension
1%
Fall
1%
Abdominal discomfort
1%
Large intestinal polypectomy
1%
Tachycardia
1%
Disturbance in attention
1%
Sepsis
1%
Gout
1%
Onychomycosis
1%
Back pain
1%
Hypertriglyceridaemia
1%
Pruritus
1%
Syncope
1%
Palpitations
1%
Basal cell carcinoma
1%
Cough
1%
Pneumomediastinum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab
Aducanumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aducanumab SCExperimental Treatment1 Intervention
Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15.
Group II: Aducanumab IVActive Control1 Intervention
Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aducanumab
2022
Completed Phase 3
~330

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,313 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,363 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216887.
~39 spots leftby Apr 2025
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