M19-304: A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients with Parkinson's Disease

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

The purpose of this study is to learn about the safety, tolerability, pharmacokinetics (the amount of drug absorbed into the blood stream), and immunogenicity (the ability of the body to generate an immune response against the drug) of ABBV-0805 following multiple ascending doses, administered every 28 days via intravenous (IV) infusions in subjects with Parkinson's disease (PD). Pharmacodynamic activity or how the drug affects the body will also be assessed.
Study participation will last about thirty-seven (37) weeks, plus time for screening. Screening takes place up to six (6) weeks prior to the first dose of study drug.

Description

For more information, contact EvergreenHealth Research Program at 425-899-5385 or EvergreenResearch@evergreenhealth.com and ask about the M19-304 study.
 

Details
Condition Parkinson's disease, Parkinson's disease
Clinical Study IdentifierTX242409
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with Idiopathic Parkinson's Disease (PD) within 5 years and with modified Hoehn and Yahr Stage of less than 3 at screening
Body Mass Index (BMI) is >= 18.0 to <=35.0 kg/m2
Participant must follow protocol-specific methods of contraception, if applicable
Participant must be in general good health (except for PD) based upon results of medical history, physical examination, vital signs, laboratory testing, neurological examination and 12-lead electrocardiogram (ECG)

Exclusion Criteria

Participant with a history of, or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space occupying lesion (such as an abscess or brain tumor such as meningioma)
Received any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study administration, unless approved by the Investigator in consultation with the sponsor's Medical Director
Treated with any investigational product within a time frame equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to the first dose of study drug
Participant with recent history of drug or alcohol abuse (within 6 months prior to study drug administration) that could impact adherence to the protocol in the opinion of the investigator
Received any live vaccine within 4 weeks prior to the first dose of study drug, including but not limited to
measles/mumps/rubella vaccine
varicella zoster virus vaccine
oral polio vaccine
nasal influenza vaccine
Participant with symptoms of an active infection or history of prior infection (viral, fungal, or bacterial) requiring hospitalization or IV antibiotics within 8 weeks before first dose of study drug
Participant with contraindications to lumbar puncture (such as lumbar scoliosis, coagulopathy, infected skin at needle puncture site). Use of anticoagulants may be allowed in the study but must be temporarily suspended prior to and after lumbar puncture
Participant with contraindications to MRI (such as aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker), are allergic to gadolinium, or have claustrophobia
Participant currently enrolled in another interventional clinical study. Participants enrolled in non-interventional studies may be eligible to participate at the discretion of the sponsor TA MD
Other inclusion/exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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