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

May 3, 2021 updated by: UCB Biopharma S.P.R.L.

A Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Up0077 102
    • Florida
      • Bay Harbor Islands, Florida, United States, 33154
        • Up0077 103
      • DeLand, Florida, United States, 32720
        • Up0077 105
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Up0077 107
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Up0077 101
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Up0077 104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 - UCB0599
Participants will be randomized to receive a predefined dosage of UCB0599.
Drug: UCB0599
Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
Experimental: Cohort 2 - UCB0599
Participants will be randomized to receive a predefined dosage of UCB0599.
Drug: UCB0599
Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
Placebo Comparator: Cohort 1 - Placebo
Participants will be randomized to receive a predefined dosage of Placebo.
Drug: Placebo
Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.
Placebo Comparator: Cohort 2 - Placebo
Participants will be randomized to receive a predefined dosage of Placebo.
Drug: Placebo
Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Avents (TEAEs) from Baseline to End of Study visit
Time Frame: From Baseline to End of study visit (up to Week 7)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline to End of study visit (up to Week 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) in healthy participants on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
Cmax: Maximum observed plasma concentration
Day 1: Predose up to 12 hours post dose
Maximum observed plasma concentration (Cmax) in healthy participants on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
Cmax: Maximum observed plasma concentration
Day 28: Predose up to 24 hours post dose
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
Tmax: Time of observed Cmax
Day 1: Predose up to 12 hours post dose
Time to maximum observed plasma concentration (tmax) in healthy participants on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
Tmax: Time of observed Cmax
Day 28: Predose up to 24 hours post dose
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in healthy participants on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
AUC(0-12h): Area under the curve from time 0 to 12 hours
Day 1: Predose up to 12 hours post dose
Area under the concentration-time curve for the dosing interval (AUCtau) in healthy participants on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Day 28: Predose up to 24 hours post dose
Maximum observed plasma concentration (Cmax) in patients on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
Cmax: Maximum observed plasma concentration
Day 1: Predose up to 12 hours post dose
Maximum observed plasma concentration (Cmax) in patients on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
Cmax: Maximum observed plasma concentration
Day 28: Predose up to 24 hours post dose
Time to maximum observed plasma concentration (tmax) in patients on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
Tmax: Time of observed Cmax
Day 1: Predose up to 12 hours post dose
Time to maximum observed plasma concentration (tmax) in patients on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
Tmax: Time of observed Cmax
Day 28: Predose up to 24 hours post dose
Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in patients on Day 1
Time Frame: Day 1: Predose up to 12 hours post dose
AUC(0-12h): Area under the curve from time 0 to 12 hours
Day 1: Predose up to 12 hours post dose
Area under the concentration-time curve for the dosing interval (AUCtau) in patients on Day 28
Time Frame: Day 28: Predose up to 24 hours post dose
AUCtau: Area under the concentration-time curve for the dosing interval at steady state
Day 28: Predose up to 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma S.P.R.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on UCB0599

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings