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

July 4, 2024 updated by: UCB Biopharma SRL

A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's Disease

The primary purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB7853 in healthy male study participants and to evaluate the safety and tolerability of multiple ascending doses of UCB7853 administered in study 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.
62

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

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Part 1 (healthy participants):

  • Participant must be male and 18 to 55 years of age inclusive
  • Body weight within 50 kg to 110 kg and body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive)
  • Participant must be healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
  • Participant has clinical laboratory test results within the reference ranges of the laboratory

Part 2 (participants with Parkinson's Disease):

  • Participant must be 40 to 80 years of age, inclusive, at the time of signing the informed consent form (ICF)
  • Participant may be male or female
  • Participant must have body weight of between 50 and 110 kg and a body mass index within the range of 18 to 32 kg/m^2 (inclusive)
  • Participant must have a clinical diagnosis of Parkinson's disease (PD) according to the Movement Disorders Society criteria. The following diagnostic criteria must be met: Bradykinesia AND at least ONE of the following: muscular rigidity or resting tremor
  • Participant must have a Hoehn and Yahr Stage of ≤3
  • 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
  • Participant must be in good physical and mental health, in particular not affected by any neurological disorder other than Parkinson's disease (PD), in the opinion of the Investigator, determined on the basis of medical history and a general clinical examination at Screening
  • Participant has clinical laboratory test results within the reference ranges of the laboratory

Exclusion Criteria:

Part 1 (healthy participants):

  • Participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, pancreatic, musculoskeletal, genitourinary, immunological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
  • Participant has a known hypersensitivity to any components of the study medication or comparative drugs
  • Participant has any clinically relevant abnormal findings in physical examination, laboratory tests, or vital signs, which, in the opinion of the Investigator, may place the participant at risk because of participation in the study
  • Participant has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening

Part 2 (participants with Parkinson's Disease):

  • 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
  • Study participant has a history of levodopa-induced motor fluctuations or dyskinesia expected to interfere with his/her ability to participate in the study
  • Participant has a known hypersensitivity to any components of the study medication or comparative drugs
  • Study participant has had prior surgical treatment for PD involving intracranial surgery or implantation of a device (including deep brain stimulation) or duodopa
  • Participant has any clinically relevant abnormal findings in physical examination (other than symptoms of PD), laboratory tests, or vital signs, which, in the opinion of the Investigator, may place the participant at risk because of participation in the study
  • Participant has any clinically relevant brain MRI abnormality at Screening

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: Parallel 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: UCB7853
Part 1: Single intravenous infusion of UCB7853 Part 2: Multiple intravenous infusions of UCB7853 at pre-specified time-points
Drug: UCB7853
Subjects will receive UCB7853 at pre-specified time-points.
Placebo Comparator: Placebo
Part 1: Single intravenous infusion of Placebo Part 2: Multiple intravenous infusions of Placebo at pre-specified time-points
Other: Placebo
Subjects will receive Placebo at pre-specified time-points.

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
Incidence of Treatment-emergent Adverse Events (TEAEs) in healthy male participants
Time Frame: From Day 1 to the End of Study Visit (Day 141), Part 1)
A treatment-emergent Adverse Event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From Day 1 to the End of Study Visit (Day 141), Part 1)
Incidence of Treatment-emergent Adverse Events (TEAEs) in participants with Parkinson's Disease
Time Frame: From Day 1 to the End of Study Visit (Day 197), Part 2
A treatment-emergent Adverse Event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From Day 1 to the End of Study Visit (Day 197), Part 2

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
Cmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
Cmax = Maximum observed concentration
Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
Cmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
Time Frame: Samples will be taken from Day 57 to the End of Study Visit (Day 197), Part 2
Cmax = Maximum observed concentration
Samples will be taken from Day 57 to the End of Study Visit (Day 197), Part 2
AUC of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC = Area under the concentration-time curve
Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC(0-t) of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
AUC(0-t) of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
Time Frame: Samples will be taken from Day 57 to Day 85, Part 2
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Samples will be taken from Day 57 to Day 85, Part 2
tmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
tmax = Time to reach Cmax
Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
tmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
Time Frame: Samples will be taken from from Day 57 to the End of Study Visit (Day 197), Part 2
tmax = Time to reach Cmax
Samples will be taken from from Day 57 to the End of Study Visit (Day 197), Part 2
t1/2 of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
t1/2 = Terminal half-life
Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CL = Total body clearance of the drug
Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
Time Frame: Samples will be taken from from Day 57 to Day 85, Part 2
CL = Total body clearance of the drug
Samples will be taken from from Day 57 to Day 85, Part 2
Vz of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Time Frame: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
Vz = Volume of distribution during terminal phase
Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CSF/serum UCB7853 concentration ratio on Day 7 (Part 1)
Time Frame: Day 7 (Part 1)
CSF = Cerebrospinal fluid
Day 7 (Part 1)
CSF/serum UCB7853 concentration ratio on Day 63 (Part 2)
Time Frame: Day 63 (Part 2)
CSF = Cerebrospinal fluid
Day 63 (Part 2)

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 SRL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

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.
December 14, 2020

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.
July 20, 2023

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.
July 20, 2023

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).
November 25, 2020

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.
November 25, 2020

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.
December 3, 2020

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.
July 8, 2024

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.
July 4, 2024

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.
July 1, 2024

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.
  • UP0092
  • 2020-003356-32 (EudraCT Number)

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

No

Studies a U.S. FDA-regulated device product

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.

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