Phase
Condition
Myasthenia Gravis (Chronic Weakness)
Scar Tissue
Amyotrophic Lateral Sclerosis (Als)
Treatment
89Zr-DFO-AP-101
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged of:
For healthy participants: Male or female subjects aged 50 years or older
For ALS patients: Male or female subjects aged 18 years and older
Able to remain in a lying position for up to 45 minutes without respiratory support.
A) For ALS patients, confirmed diagnostic of definitive ALS according to El-Escorialcriteria14 B) for healthy participants: no neurologic condition (confirmed byphysical exam)
Have venous access sufficient to allow for blood sampling
Are reliable and willing to make themselves available for the duration of the studyand are willing to follow CRCHUS-specific study procedures.
Exclusion
Exclusion Criteria:
Are currently enrolled or were enrolled in the last 12 weeks in any other clinicaltrial involving a study drug or off label use of a drug or device, or any other typeof medical research judged not to be scientifically or medically compatible withthis study.
Female participants who are pregnant or breast feeding; or women of childbearingpotential (<50 years old) and men who are sexually active who are not willing to usean accepted effective contraceptive method.
Plan to have surgery or other invasive procedure during the course of the study (upto 14 days post-injection)
Have a progressive medical illness including, but not limited to, anycardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric orneurological disease, convulsions, or any clinically significant laboratoryabnormality at screening and at first visit (D0) that, in the judgment of themedical doctor, indicate a medical problem that would preclude study participation.
Have one of these conditions (for both patient groups):
hepatic disorder such as hepatic encephalopathy, hepatic laboratoryabnormalities (ALT or AST ≥3 × ULN or total bilirubin ≥2 × ULN) and hematologyabnormalities at screening.
severe chronic kidney disease (eg, an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m or requires chronic dialysis) at screening.
Have severe active psychiatric illness.
Have a diagnosis of another neurodegenerative disease (e.g. Parkinson disease,Alzheimer's disease, etc).
Have a significant infection or known inflammatory process on screening or atDay 0.
Alcohol or drug abuse based on patient auto-report
Have a history of relevant atopy or drug hypersensitivity or allergy toantibodies;
Have an abnormal blood pressure (supine) defined as a diastolic blood pressure >90 or <45 mmHg and/or a systolic blood pressure >160 or <90 mmHg. Re-testingmay occur once during the screening visit within 2 hours of the initialabnormal blood pressure measurement at the discretion of the investigator.
For ALS patients:
Have undergone a tracheostomy for ALS symptoms.
Are on nasal intermittent positive pressure ventilation (NIPPV) >4h during theday, while awake for the treatment of ALS related symptoms.
Have other causes of neuromuscular weakness.
Have received treatment with biologic agents (such as monoclonal antibodies,including marketed drugs and AP-101) within 3 months or 5 half-lives (whichever islonger) prior to study drug injection.
Have received any blood or blood products within the 3 months prior to screening.
Cannot communicate reliably with the investigator.
Are unwilling or unable to give written informed consent.
In the opinion of the medical doctor or his/her delegate, are unsuitable forinclusion in the study.
Study Design
Study Description
Connect with a study center
CIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available

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