Parkinson's DiseasePhase 1NCT04651153
A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)
A Phase 1 study testing UCB7853 in people with Parkinson's Disease, run by UCB Biopharma SRL at 2 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- UCB7853
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Dec 2020to 20 Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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):
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- UCB7853, Placebo
- Keywords
- Parkinson's Disease, Phase 1, Healthy Volunteers, Patients
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB7853Drug
Subjects will receive UCB7853 at pre-specified time-points.
PlaceboOther
Subjects will receive Placebo at pre-specified time-points.
| Study group | Role | What they receive |
|---|---|---|
| UCB7853 | Experimental | Part 1: Single intravenous infusion of UCB7853 Part 2: Multiple intravenous infusions of UCB7853 at pre-specified time-points Receives: Drug: UCB7853 |
| Placebo | Placebo comparator | Part 1: Single intravenous infusion of Placebo Part 2: Multiple intravenous infusions of Placebo at pre-specified time-points Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Cmax = Maximum observed concentration
Measured: 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
Cmax = Maximum observed concentration
Measured: 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
AUC = Area under the concentration-time curve
Measured: 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
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Measured: 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
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
Measured: Samples will be taken from Day 57 to Day 85, Part 2
tmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
tmax = Time to reach Cmax
Measured: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
tmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
tmax = Time to reach Cmax
Measured: Samples will be taken from from Day 57 to the End of Study Visit (Day 197), Part 2
t1/2 of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
t1/2 = Terminal half-life
Measured: Samples will be taken from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of single ascending doses in healthy male participants
CL = Total body clearance of the drug
Measured: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CL of UCB7853 after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease
CL = Total body clearance of the drug
Measured: Samples will be taken from from Day 57 to Day 85, Part 2
Vz of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants
Vz = Volume of distribution during terminal phase
Measured: Samples will be taken from from Day 1 to the End of Study Visit (Day 141), Part 1
CSF/serum UCB7853 concentration ratio on Day 7 (Part 1)
CSF = Cerebrospinal fluid
Measured: Day 7 (Part 1)
CSF/serum UCB7853 concentration ratio on Day 63 (Part 2)
CSF = Cerebrospinal fluid
Measured: Day 63 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start14 Dec 2020
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT04651153
- Sponsor's protocol ID
- UP0092
- Other IDs
- 2020-003356-32
- Status last verified
- Jul 2024
- First submitted
- 25 Nov 2020
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04651153
- Acronym / sponsor ID
- UP0092
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Phase 1, Healthy Volunteers, Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 3 Dec 2020 (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 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB7853 | Experimental | Drug: UCB7853Part 1: Single intravenous infusion of UCB7853 Part 2: Multiple intravenous infusions of UCB7853 at pre-specified time-points |
| Placebo | Placebo comparator | Other: PlaceboPart 1: Single intravenous infusion of Placebo Part 2: Multiple intravenous infusions of Placebo at pre-specified time-points |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Participant must be 40 to 80 years of age, inclusive, at the time of signing the informed consent form (ICF)
Key exclusion criteria (12 listed)
- 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
- 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
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 |
|---|---|---|
| UCB7853Subjects will receive UCB7853 at pre-specified time-points. | Drug | UCB7853 |
| PlaceboSubjects will receive Placebo at pre-specified time-points. | Other | Placebo |
Primary outcome
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.
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.
13 secondary outcomes
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 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
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(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) 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
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 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
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
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 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
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
CSF/serum UCB7853 concentration ratio on Day 7 (Part 1)
Time frame: Day 7 (Part 1)
CSF/serum UCB7853 concentration ratio on Day 63 (Part 2)
Time frame: Day 63 (Part 2)
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 8 Jul 2024.
- 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)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB7853 in people with Parkinson's Disease, run by UCB Biopharma SRL at 2 sites in 2 countries.
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 14 inclusion and 12 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, 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?
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)). The study lists 2 primary outcomes in all. 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 8 Jul 2024.