A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2020-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the safety and tolerability after administration of multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in healthy study participants and participants with Parkinson's Disease (PD).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

NCT04658186

Early-stage Parkinson's Disease

COMPLETED PHASE2

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

NCT06055985

Parkinson Disease

COMPLETED PHASE2

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)

NCT04651153

Parkinson's Disease

COMPLETED PHASE1

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

NCT06189170

Safety Issues Tolerance

RECRUITING EARLY_PHASE1

PF-06669571 In Subjects With Idiopathic Parkinson's Disease

NCT02565628

Idiopathic Parkinson's Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1 - UCB0599

Participants will be randomized to receive a predefined dosage of UCB0599.

Group Type EXPERIMENTAL

UCB0599

Intervention Type DRUG

Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.

Cohort 2 - UCB0599

Participants will be randomized to receive a predefined dosage of UCB0599.

Group Type EXPERIMENTAL

UCB0599

Intervention Type DRUG

Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.

Cohort 1 - Placebo

Participants will be randomized to receive a predefined dosage of Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.

Cohort 2 - Placebo

Participants will be randomized to receive a predefined dosage of Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UCB0599

Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.

Intervention Type DRUG

Placebo

Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent
* Study participant with Parkinson's disease (PD) must have a clinical diagnosis of PD. The following diagnostic criteria must be met: Bradykinesia AND at least ONE of the following: muscular rigidity or resting tremor
* Study participant with PD must have a historic brain image (magnetic resonance imaging (MRI) or computerized tomography (CT) obtained at any point from the time of clinical diagnosis to the time of Screening that does not show any brain abnormalities that could cause symptomatic Parkinsonism
* Study participant must have a Hoehn and Yahr Stage: 1 to 3
* Study participant must be either untreated, or treated with a stable regimen (at least 4 weeks prior to Baseline Visit) of antiparkinsonian drugs and is expected to remain on this regimen for the duration of the study
* Body weight \>50 kg (110 lbs) and body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive)

Exclusion Criteria

* Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
* Study participant has a known relevant allergy, a pre-existing history of a relevant allergic condition, or a predisposition for an allergic reaction (ie, total immunoglobulin E \[IgE\] value above normal range at Screening); this study participant's inclusion should be discussed with the Medical Monitor
* Study participant has a history of levodopa-induced motor fluctuations or dyskinesia expected to interfere with his/her ability to participate in the study
* Study participant has ongoing significant inflammatory gastrointestinal disorders and/or clinical signs of significant gastrointestinal problems at Screening
* Study participant has a historic brain scan (MRI scan or CT scan) or an MRI scan performed at Screening indicative of a clinically significant abnormality
* Study participant has a diagnosis of a significant Central nervous system (CNS) disease other than PD or history of epilepsy or seizure disorder other than febrile seizures as a child
* Abnormalities in lumbar spine previously known or determined by a screening lumbar x-ray (if conducted)
* History of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose participant to complications or technical difficulty with lumbar puncture
* Evidence or history of significant active bleeding or coagulation disorder or use of drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Study participant has a history or present condition of respiratory or cardiovascular disorders at Screening (eg, cardiac insufficiency, coronary heart disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) which is considered clinically significant by the Investigator
* Study participant has medical history or current diagnosis of diabetes
* Study participant has clinical significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator
* Study participant has had prior treatment with an investigational vaccine for PD (including active immunization or passive immunotherapy with monoclonal antibodies)
* Study participant has had prior surgical treatment of PD involving intracranial surgery or implantation of a device (including deep brain stimulation) or duodopa

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes