A safety and pharmacokinetics study of UCB0599 in patients with Parkinson's disease

A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF UCB0599 IN PATIENTS WITH PARKINSON’S DISEASE (PD)

Recruitment Information:

Seeking volunteers with following diagnosis: PD, Control Volunteers Accepted Study Type: Interventional
Eligible Ages: 40 - 80 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

The most urgent unmet medical need in Parkinson's disease is a treatment targeting the underlying disease mechanism and thus prevent the disease from progressing rather than only controlling symptoms. The study drug tested in this study is a new chemical compound called UCB0599, which could have such effects by preventing the aggregation of alpha-synuclein in the brain, which is thought to be the main driver of the disease progression. This is strongly supported by studies in animals but it is still unknown if UCB0599 will provide real benefit to humans. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple doses of UCB0599. Pharmacokinetics means measuring the amount of the study drug in the blood and how long it stays in the body. For this purpose, Study Participants will be randomly (by chance) assigned to receive either the study drug or a placebo, both provides as capsules. A placebo is a “dummy” capsule without UCB0599. Participation in this research will require participants to stay in a clinic or trial unit for 30 days (28 days of treatment and 2 days for safety follow-up). The study drug differs from purely symptomatic drugs currently available and may improve the medical care of patients who do not respond to, or cannot tolerate current drug treatments for Parkinson’s disease. The drug also has the potential to have a positive effect on a much broader range of symptoms of PD, including non-motor ones (like cognitive issues). The study is expected to provide critical safety and PK data required for a larger study to test if the drug works in PD patients.

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More Details

The study has two groups, each testing a different dose of UCB0599. The dose you receive will depend on when you enter the study. Further features of the will increase our scientific understanding of the disease (“exploratory endpoints”): We plan to look at the effects of the study drug on alpha-synuclein and other “biomarkers” in blood and cerebrospinal fluid. We also plan to compare the UCB0599 concentration in blood collected in two different ways:: First collected the traditional way (from a vein) and second a small amount of blood collected from a finger prick (this new way is optional). In the future, this new technology may make blood collection easier for patients. CSF will be collected by a spinal tap.

Phase: Phase 1 Lead Sponsor: UCB Biopharma SPRL
Trial ID: 006336 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors: ICON
Estimated Enrollment: 27 Study Start Date: May 2019
Estimated Study Completion Date: May 2020 Source:
Study Website:
This is a FDA Regulated Trial

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