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

NCT04651153 | Completed Phase 1

• 2 other identifiers: UP00922020-003356-32
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 2

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)

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Cmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants

  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

  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

  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

  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

  Samples will be taken from Day 57 to Day 85, Part 2

Study Arms (2)

UCB7853

EXPERIMENTAL

Part 1: Single intravenous infusion of UCB7853 Part 2: Multiple intravenous infusions of UCB7853 at pre-specified time-points

Drug: UCB7853

Placebo

PLACEBO COMPARATOR

Part 1: Single intravenous infusion of Placebo Part 2: Multiple intravenous infusions of Placebo at pre-specified time-points

Other: Placebo

Interventions

UCB7853 DRUG

Subjects will receive UCB7853 at pre-specified time-points.

UCB7853

Placebo OTHER

Subjects will receive Placebo at pre-specified time-points.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (2)

Up0092 201

Leiden, Netherlands

Location

Up0092 101

London, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: December 14, 2020
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (1)