The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
UC San Diego, ACTRI
La Jolla, California, United States
Department of Neurology, University Hospitals
Leuven, Belgium
ALS clinic at the Kaye Edmonton Clinic, University of Alberta
Edmonton, Alberta, Canada
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations.
Time frame: From start of the study up to Week 51
Number of Participants with Abnormalities in Vital Signs, Clinical Laboratory Assessments, Physical and Neurological Examinations, Electrocardiograms (ECGs)
Time frame: From start of the study up to Week 51
Elimination half-life (t1/2) of AP-101 in Serum
Time frame: Predose up to Week 51
Area Under the Drug Concentration-Time Curve (AUC)
Time frame: Predose up to Week 51
Concentration at End of Infusion (Cat EOI)
Time frame: Week 24
Change From Baseline in AP-101 Levels in the Cerebrospinal Fluid (CSF) up to Week 24
Time frame: Baseline, up to Week 24
Change From Baseline in Neurofilament Light Chain and Phospho-Neurofilament Heavy Chain Levels in the Cerebrospinal Fluid (CSF) up to Week 51
Time frame: Baseline, up to Week 51
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London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
ALS Research Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital / Dr Genge
Montreal, Quebec, Canada
Hannover Medical School
Hanover, Hanover, Germany
Charité
Berlin, State of Berlin, Germany
Ulm University Hospital
Ulm, Ulm, Germany
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
Bonn, Germany
...and 3 more locations
Change From Baseline in Neurofilament Light Chain and Phospho-Neurofilament Heavy Chain Levels in Plasma up to Week 51
Time frame: Baseline, up to Week 51