We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04867642
Previous Study | Return to List | Next Study

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease

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: NCT04867642
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.

Condition or disease Intervention/treatment Phase
Healthy Study Participants Parkinson's Disease Drug: UCB0022 Other: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study consists of a crossover design part (Part A) and two parts (Part B and Part C) with a parallel design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a participant- and investigator-blind study.
Primary Purpose: Basic Science
Official Title: A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : December 29, 2022
Estimated Study Completion Date : December 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A Sequence 1
Study participants randomized to Part A will receive single ascending doses of UCB0022 or placebo (PBO) at pre-specified time points during the Treatment Period of alternating cohorts in a crossover design.
Drug: UCB0022
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.

Other: Placebo
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other Name: PBO

Experimental: Part A Sequence 2
Study participants randomized to Part A will receive single ascending doses of UCB0022 or placebo (PBO) at pre-specified time points during the Treatment Period of alternating cohorts in a crossover design.
Drug: UCB0022
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.

Other: Placebo
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other Name: PBO

Experimental: Part B UCB0022
Study participants randomized to Part B will receive multiple ascending doses of UCB0022 at pre-specified time points during the Treatment Period of cohorts in a parallel design.
Drug: UCB0022
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.

Placebo Comparator: Part B Placebo
Study participants randomized to Part B will receive placebo (PBO) comparator at pre-specified time points during the Treatment Period of cohorts in a parallel design.
Other: Placebo
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other Name: PBO

Experimental: Part C UCB0022
Study participants randomized to this cohort in Part C will receive fixed multiple doses of UCB0022 at pre-specified time points during the Treatment Period.
Drug: UCB0022
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.

Placebo Comparator: Part C Placebo
Study participants randomized to this cohort in Part C will receive placebo (PBO) comparator at pre-specified time points during the Treatment Period.
Other: Placebo
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other Name: PBO




Primary Outcome Measures :
  1. Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C) ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment.


Secondary Outcome Measures :
  1. Maximum plasma concentration (cmax) for each single dose of UCB0022 in Part A [ Time Frame: From Day 1 (predose) at predefined time points (up to Day 3) ]
    Cmax: Maximum plasma concentration for each pre-specified single dose in Part A

  2. Time to maximum plasma concentration (tmax) for each single dose of UCB0022 in Part A [ Time Frame: From Day 1 (predose) at predefined time points (up to Day 3) ]
    tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A

  3. Area under the plasma concentration-time curve from time zero to infinity (AUC) for a each dose of UCB0022 in Part A [ Time Frame: From Day 1 (predose) at predefined time points (up to Day 3) ]
    AUC (AUCinfinity): Area under the UCB0022 plasma concentration-time curve from time zero to infinity for a each dose in Part A

  4. Maximum plasma concentration during a dosing interval through steady state (Cmax, ss) for each dose UCB0022 in Part B and C [ Time Frame: From Day 1 (predose) at predefined time points (up to Day 16) ]
    Cmax, ss: Maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C

  5. Time to maximum plasma concentration during a dosing interval through steady state (tmax, ss) for each dose UCB0022 in Part B and C [ Time Frame: From Day 1 (predose) at predefined time points (up to Day 16) ]
    tmax, ss: time to maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C

  6. Area under the plasma concentration-time curve at steady state (AUCtau) on Day 1 for a each dose of UCB0022 in Part B and C [ Time Frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16) ]
    AUCtau: Area under the plasma concentration-time curve at steady state on Day 1 for a each dose of UCB0022 in Part B and C

  7. Area under the plasma concentration-time curve at steady state (AUCtau) on Day 14 for a each dose of UCB0022 in Part B and C [ Time Frame: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16) ]
    AUCtau: Area under the plasma concentration-time curve at steady state on Day 14 for a each dose of UCB0022 in Part B and C



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be 18 to 55 years of age inclusive or 35 to 75 years for part C, at the time of signing the informed consent
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
  • Study participant has a blood pressure (BP) and heart rate (HR) before the first dose, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 130 millimeters of mercury (mmHg), mean diastolic BP ranging between 50 and 80 mmHg, and mean HR between 45 and 90 beats per minute (bpm)
  • Participant has a body weight of at least 45 kg and body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive)
  • Participants are male or female:
  • A male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

Not a woman of childbearing potential (WOCBP) as defined in the protocol OR A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment

Part C only:

  • Patient must have a documented history of idiopathic Parkinson's disease confirmed by a neurologist, and with no other atypical or secondary parkinsonism (eg, multiple-system atrophy, progressive supranuclear palsy, or evidence of drug-induced parkinsonism)
  • Participants with Hoehn and Yahr Stages of 1 to 3 inclusive, (Hoehn and Yahr, 1967) at Screening when in the ON state
  • Participants on stable dosage of all anti-Parkinsonian therapy for at least 30 days prior to first investigational medicinal product (IMP) administration (with the exception that MAO-B inhibitors that must be maintained at a stable level for at least 8 weeks prior), and it is anticipated that no changes will be needed during the course of the study
  • Participant has a BP and HR at Screening, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 140 mmHg, mean diastolic BP ranging between 50 and 90 mmHg, and a mean HR between 50 and 90 bpm

Exclusion Criteria:

  • Participant has history or presence of cerebro/cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, psychiatric 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 high risk for cardiovascular accident based on family history or on laboratory test
  • Participants with hypertension requiring medical treatment within 6 months before the Screening, or with clinically significant orthostatic hypotension
  • Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
  • Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
  • Participant has active neoplastic disease or history within the past 5 years of screening visit except for basal cell or squamous epithelial carcinomas of the skin that have been treated with SOC. Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
  • Participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing
  • Participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing
  • Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
  • Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Participant has a current history of alcohol or drug use disorder within the last Y Statistical Manual of Mental Disorders Version 5 (DSM-5), within the last year
  • Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline
  • Participant has the presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing
  • Participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention
  • Participant has a positive human immunodeficiency virus (HIV) antibody test
  • Participant has clinical signs and symptoms consistent with COVID-19 or had a positive Sars-Cov-2 test result within the last 4 weeks prior to dosing
  • Active treatment or a history of glaucoma

Part C only:

  • Participant with implantable intracranial stimulator or history of intracranial surgery
  • Participant with documented diagnosis of dementia or a Montreal Cognitive Assessment (MoCA) score <26 at screening
  • Participant with history of psychotic symptoms (including significant hallucinations) requiring treatment with an antipsychotic medication within the 12 months prior to Admission

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): NCT04867642


Contacts
Layout table for location contacts
Contact: UCB Cares 001 844 599 2273 UCBCares@ucb.com

Locations
Layout table for location information
United Kingdom
Up0091 001 Recruiting
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
Layout table for investigator information
Study Director: UCB Cares 001 844 599 2273 (UCB)
Layout table for additonal information
Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04867642    
Other Study ID Numbers: UP0091
2020-003111-10 ( EudraCT Number )
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 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.

Layout table for additional information
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 ):
Healthy Study Participants
Parkinson's Disease
Phase 1
escalating cohorts
UCB0022
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases