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

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: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: UCB7853; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Up0092 201
• United Kingdom
  • London, United Kingdom
    • Up0092 101

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-emergent Adverse Events (TEAEs) in healthy male participants	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	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

Outcome Measure	Measure Description	Time Frame
Cmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants	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	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	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	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	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	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	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	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	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	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	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)	CSF = Cerebrospinal fluid	Day 7 (Part 1)
CSF/serum UCB7853 concentration ratio on Day 63 (Part 2)	CSF = Cerebrospinal fluid	Day 63 (Part 2)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Healthy Volunteers; Patients; Phase 1
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID 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