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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04651153
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : November 24, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 : November 24, 2023
Estimated Study Completion Date : November 24, 2023

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04651153


Contacts
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Contact: UCB Cares 1-844-599-2273 (USA) UCBCares@ucb.com
Contact: UCB Cares 0018445992273 UCBCares@ucb.com

Locations
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Netherlands
Up0092 201 Recruiting
Leiden, Netherlands
United Kingdom
Up0092 101 Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04651153    
Other Study ID Numbers: UP0092
2020-003356-32 ( EudraCT Number )
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: November 24, 2022
Last Verified: November 2022
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.

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