Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with diagnosis of familial or sporadic ALS
Onset of muscle weakness no more than 30 months before screening visit.
Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and height at Screening.
If on riluzole, the dose must have been stable for at least 28 days prior to Baseline visit.
Age 18 - 80 years inclusive.
Female subjects may participate if they are of non-child-bearing potential or if they are of child-bearing potential they must agree to use the approved contraceptive methods
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin \<=1.5xULN.
QTc (both QTcB and QTcF) \<450 milliseconds (msec) or \<480 msec for subjects with Bundle Branch Block at Screening and Baseline (average from triplicate ECGs).
You may not be if
Patients with other neuromuscular disorders (including a history of polio) which in the opinion of the investigator could have contributed to the muscular atrophy or weakness caused by ALS
Patients with primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia complex.
Patients requiring non-invasive or mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed subject to discussion with Medical Monitor)
Patients on diaphragmatic pacing.
Presence of any of the following clinical conditions: Drug abuse or alcoholism, uncontrolled hypertension, active major infectious disease, unstable psychiatric illness within 90 days of the Screening visit
Subjects, who in the investigator's judgement, pose a significant suicide risk. - Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), positive Hepatitis B surface antigen or Hepatitis C antibody test.
Subjects who have participated in a clinical trial involving receipt of a biopharmaceutical product within 6 months prior to the first dosing day.
Exposure to non-biological experimental agents 1 month or 5 half-lives prior to Baseline visit (whichever is longer).
History of sensitivity to ozanezumab, or components thereof, or a history of other allergies that, in the opinion of the investigator, contraindicates participation in the study.
