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

• ClinicalTrials.gov Identifier: NCT04651153
• Recruitment Status: Active, not recruiting
• First Posted: December 3, 2020
• Last Update Posted: March 13, 2023
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Study Description

Brief Summary:

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)

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Drug: UCB7853; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: December 14, 2020
• Estimated Primary Completion Date: July 21, 2023
• Estimated Study Completion Date: July 21, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. CSF/serum UCB7853 concentration ratio on Day 7 (Part 1) [ Time Frame: Day 7 (Part 1) ]
    CSF = Cerebrospinal fluid
13. CSF/serum UCB7853 concentration ratio on Day 63 (Part 2) [ Time Frame: Day 63 (Part 2) ]
    CSF = Cerebrospinal fluid

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Netherlands

Up0092 201

Leiden, Netherlands

United Kingdom

Up0092 101

London, United Kingdom

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

• Study Director: UCB Cares; 001 844 599 2273 (UCB)

More Information

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT04651153
• Other Study ID Numbers: UP0092; 2020-003356-32 ( EudraCT Number )
• First Posted: December 3, 2020
• Last Update Posted: March 13, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma SRL ):

Parkinson's Disease; Phase 1; Healthy Volunteers; Patients

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases