This study will evaluate the safety and tolerability of ABBV-0805 in adult participants with Parkinson's Disease and results from it will help guide the design of future clinical studies. ABBV-0805 is administered every 28 days by intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
ABBV-0805 administered by IV infusion.
Placebo ABBV-0805 administered by IV infusion.
University of Florida - Archer /ID# 212823
Gainesville, Florida, United States
Columbia Univ Medical Center /ID# 212826
New York, New York, United States
Duke University Medical Center /ID# 214435
Durham, North Carolina, United States
Evergreen Neuroscience Institute /ID# 212827
Kirkland, Washington, United States
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time frame: Day 1 through Day 260
Maximum Observed Serum Concentration (Cmax)
Maximum Serum Concentration of ABBV-0805.
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Time to Cmax (peak time, Tmax)
Time to Cmax (peak time, Tmax).
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Area under the Serum Concentration Time curve (AUC)
Area Under the Serum Concentration Time Curve at first and final dose.
Time frame: Day 1 through Day 29 and Day 85 through Day 113
Apparent Terminal Phase Elimination Rate Constant (Beta)
Apparent terminal phase elimination rate constant (Beta) for ABBV-0805.
Time frame: Day 1 through Day 176
Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF)
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Inland Northwest Research /ID# 212119
Spokane, Washington, United States
University of Puerto Rico, Medical Sciences Campus /ID# 215751
Rio Piedras, Puerto Rico
Concentration of ABBV-0805 in CSF.
Time frame: Day 113
Terminal Phase Elimination half-life (t1/2)
Terminal phase elimination half-life (t1/2).
Time frame: Day 1 through Day 176
Serum Concentration (Ctrough)
Ctrough concentration of ABBV-0805.
Time frame: Day 29, Day 57, Day 85, Day 113
Total clearance (CL)
Clearance of ABBV-0805.
Time frame: Day 1 through Day 176