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Strategic considerations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-0805 Dose 1 or Placebo | Experimental | Participants will receive ABBV-0805 Dose 1 or Placebo. |
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| ABBV-0805 Dose 2 or Placebo | Experimental | Participants will receive ABBV-0805 Dose 2 or Placebo. |
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| ABBV-0805 Dose 3 or Placebo | Experimental | Participants will receive ABBV-0805 Dose 3 or Placebo. |
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| ABBV-0805 Dose 4 or Placebo | Experimental | Participants will receive ABBV-0805 Dose 4 or Placebo. Note: This dosing group may be added after a review of data from dosing groups 1-3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-0805 | Drug | ABBV-0805 administered by IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 through Day 260 |
| Maximum Observed Serum Concentration (Cmax) | Maximum Serum Concentration of ABBV-0805. | Day 1 through Day 29 and Day 85 through Day 113 |
| Time to Cmax (peak time, Tmax) | Time to Cmax (peak time, Tmax). | 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. | 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. | Day 1 through Day 176 |
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Inclusion Criteria:
Note: If participant is taking standard of care medication for treatment of PD, doses must be stable for at least 30 days prior to starting study drug and participant should not have any clinically relevant motor fluctuations.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida - Archer /ID# 212823 | Gainesville | Florida | 32610 | United States | ||
| Columbia Univ Medical Center /ID# 212826 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo ABBV-0805 | Drug | Placebo ABBV-0805 administered by IV infusion. |
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| Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF) | Concentration of ABBV-0805 in CSF. | Day 113 |
| Terminal Phase Elimination half-life (t1/2) | Terminal phase elimination half-life (t1/2). | Day 1 through Day 176 |
| Serum Concentration (Ctrough) | Ctrough concentration of ABBV-0805. | Day 29, Day 57, Day 85, Day 113 |
| Total clearance (CL) | Clearance of ABBV-0805. | Day 1 through Day 176 |
| New York |
| New York |
| 10032-3725 |
| United States |
| Duke University Medical Center /ID# 214435 | Durham | North Carolina | 27705-4410 | United States |
| Evergreen Neuroscience Institute /ID# 212827 | Kirkland | Washington | 98034-3029 | United States |
| Inland Northwest Research /ID# 212119 | Spokane | Washington | 99202-1342 | United States |
| University of Puerto Rico, Medical Sciences Campus /ID# 215751 | Rio Piedras | 00935 | Puerto Rico |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |