A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 27 December 2021
• Main ID: NCT04127695
• Date of registration: 09/10/2019
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease
• Scientific 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
• Date of first enrolment: March 3, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04127695
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: ABBV-0805

Drug: Placebo ABBV-0805

Primary Outcome(s)

Time to Cmax (peak time, Tmax) [Time Frame: Day 1 through Day 29 and Day 85 through Day 113]

Apparent Terminal Phase Elimination Rate Constant (Beta) [Time Frame: Day 1 through Day 176]

Serum Concentration (Ctrough) [Time Frame: Day 29, Day 57, Day 85, Day 113]

Maximum Observed Serum Concentration (Cmax) [Time Frame: Day 1 through Day 29 and Day 85 through Day 113]

Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF) [Time Frame: Day 113]

Terminal Phase Elimination half-life (t1/2) [Time Frame: Day 1 through Day 176]

Total clearance (CL) [Time Frame: Day 1 through Day 176]

Area under the Serum Concentration Time curve (AUC) [Time Frame: Day 1 through Day 29 and Day 85 through Day 113]

Number of Participants with Adverse Events [Time Frame: Day 1 through Day 260]

Secondary ID(s)

M19-304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors