Clinical trial NCT04127695: A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-10-15
Enrollment: 0
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

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:

* 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 AbbVie Therapeutic Area 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.
* Participant with evidence of dysplasia or history of malignancy with the exception of excised or treated cervical cancer, some indolent malignancies (such as basal cell carcinoma or squamous cell carcinomas), remission from any malignancy for more than 5 years or participants with slow growth prostatic carcinoma may be eligible to participate with the permission of the AbbVie TA MD.
* Participant with history of seizure disorder or unexplained blackouts or history of a seizure within 6 months.
* Participant with congenital structural or conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmias or other cardiac conditions.
* Participant with varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before randomization.
* 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, and 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 history of abnormal laboratory result that, in the opinion of the investigator, are indicative of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological, and/or other major disease.
* 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 AbbVie TA MD.
* Participant with clinically significant and/or unstable medical conditions or any other reason that the Investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive ABBV-0805.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Day 1 through Day 260
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Day 1 through Day 29 and Day 85 through Day 113
measure: Time to Cmax (peak time, Tmax)
timeFrame: Day 1 through Day 29 and Day 85 through Day 113
measure: Area under the Serum Concentration Time curve (AUC)
timeFrame: Day 1 through Day 29 and Day 85 through Day 113
measure: Apparent Terminal Phase Elimination Rate Constant (Beta)
timeFrame: Day 1 through Day 176
measure: Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF)
timeFrame: Day 113
measure: Terminal Phase Elimination half-life (t1/2)
timeFrame: Day 1 through Day 176
measure: Serum Concentration (Ctrough)
timeFrame: Day 29, Day 57, Day 85, Day 113
measure: Total clearance (CL)
timeFrame: Day 1 through Day 176
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 212823
state: Florida
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 212826
state: New York
city: Durham
country: United States
facility: Duke University Medical Center /ID# 214435
state: North Carolina
city: Kirkland
country: United States
facility: Evergreen Neuroscience Institute /ID# 212827
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research /ID# 212119
state: Washington
city: Rio Piedras
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus /ID# 215751
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: