Healthy Study ParticipantsPhase 1NCT04867642
A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease
A Phase 1 study testing UCB0022 in people with Healthy Study Participants and Parkinson's Disease, run by UCB Biopharma SRL at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants, Parkinson's Disease
- What is being tested?
- UCB0022
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2021to 27 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.
- Conditions
- Healthy Study Participants, Parkinson's Disease
- Being tested
- UCB0022, Placebo
- Keywords
- Healthy Study Participants, Parkinson's Disease, Phase 1, escalating cohorts, UCB0022
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0022Drug
Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B, C and D.
PlaceboOther
Also called PBO
Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
| Study group | Role | What they receive |
|---|---|---|
| Part A Sequence 1 | Experimental | 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. Receives: Drug: UCB0022; Other: Placebo |
| Part A Sequence 2 | Experimental | 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. Receives: Drug: UCB0022; Other: Placebo |
| Part B UCB0022 | Experimental | 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. Receives: Drug: UCB0022 |
| Part B Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| Part C UCB0022 | Experimental | 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. Receives: Drug: UCB0022 |
| Part C Placebo | Placebo comparator | Study participants randomized to this cohort in Part C will receive placebo (PBO) comparator at pre-specified time points during the Treatment Period. Receives: Other: Placebo |
| Part D UCB0022 | Experimental | Study participants randomized to this cohort in Part D will receive a single dose of UCB0022 at a pre-specified time point during the Treatment Period. Receives: Drug: UCB0022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-emergent adverse events (TEAEs)
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.
Measured: From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C)
Secondary outcomes (7)
Maximum plasma concentration (cmax) for each single dose of UCB0022 in Part A
Cmax: Maximum plasma concentration for each pre-specified single dose in Part A
Measured: From Day 1 (predose) at predefined time points (up to Day 3)
Time to maximum plasma concentration (tmax) for each single dose of UCB0022 in Part A
tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A
Measured: From Day 1 (predose) at predefined time points (up to Day 3)
Area under the plasma concentration-time curve from time zero to infinity (AUC) for a each dose of UCB0022 in Part A
AUC (AUCinfinity): Area under the UCB0022 plasma concentration-time curve from time zero to infinity for a each dose in Part A
Measured: From Day 1 (predose) at predefined time points (up to Day 3)
Maximum plasma concentration during a dosing interval through steady state (Cmax, ss) for each dose UCB0022 in Part B and C
Cmax, ss: Maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
Measured: From Day 1 (predose) at predefined time points (up to Day 16)
Time to maximum plasma concentration during a dosing interval through steady state (tmax, ss) for each dose UCB0022 in Part B and C
tmax, ss: time to maximum plasma concentration during a dosing interval through steady state for each dose UCB0022 in Part B and Part C
Measured: From Day 1 (predose) at predefined time points (up to Day 16)
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
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
Measured: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
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
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
Measured: From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start29 Apr 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study consists of a crossover design part (Part A), two parts (Part B and Part C) with a parallel design and the open-label Part D.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867642
- Sponsor's protocol ID
- UP0091
- Other IDs
- 2020-003111-10
- Status last verified
- Nov 2025
- First submitted
- 27 Apr 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04867642
- Acronym / sponsor ID
- UP0091
- Conditions
- Healthy Study Participants, Parkinson's Disease
- Keywords
- Healthy Study Participants, Parkinson's Disease, Phase 1, escalating cohorts, UCB0022
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- The study consists of a crossover design part (Part A), two parts (Part B and Part C) with a parallel design and the open-label Part D.
| Arm | Type | Receives |
|---|---|---|
| Part A Sequence 1 | Experimental | Drug: UCB0022, Other: PlaceboStudy 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. |
| Part A Sequence 2 | Experimental | Drug: UCB0022, Other: PlaceboStudy 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. |
| Part B UCB0022 | Experimental | Drug: UCB0022Study 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. |
| Part B Placebo | Placebo comparator | Other: PlaceboStudy 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. |
| Part C UCB0022 | Experimental | Drug: UCB0022Study participants randomized to this cohort in Part C will receive fixed multiple doses of UCB0022 at pre-specified time points during the Treatment Period. |
| Part C Placebo | Placebo comparator | Other: PlaceboStudy participants randomized to this cohort in Part C will receive placebo (PBO) comparator at pre-specified time points during the Treatment Period. |
| Part D UCB0022 | Experimental | Drug: UCB0022Study participants randomized to this cohort in Part D will receive a single dose of UCB0022 at a pre-specified time point during the Treatment Period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB0022Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B, C and D. | Drug | Part A Sequence 1, Part A Sequence 2, Part B UCB0022, Part C UCB0022, Part D UCB0022 |
| PlaceboAlso: PBOStudy participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C. | Other | Part A Sequence 1, Part A Sequence 2, Part B Placebo, Part C Placebo |
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB0022 in people with Healthy Study Participants and Parkinson's Disease, run by UCB Biopharma SRL at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.