A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-emergent Adverse Events (TEAEs) in healthy male participants [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 [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
- 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 = Maximum observed concentration
- 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]
Cmax = Maximum observed concentration
- 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 = Area under the concentration-time curve
- 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) = Area under the concentration-time curve from time 0 to time t
- 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]
AUC(0-t) = Area under the concentration-time curve from time 0 to time t
- tmax 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]
tmax = Time to reach Cmax
- tmax of UCB7853 in serum after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease [Samples will be taken from from Day 57 to the End of Study Visit (Day 197), Part 2]
tmax = Time to reach Cmax
- t1/2 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]
t1/2 = Terminal half-life
- CL of UCB7853 after intravenous infusion of single ascending doses in healthy male participants [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
- CL of UCB7853 after intravenous infusion of multiple ascending doses in study participants with Parkinson's Disease [Samples will be taken from from Day 57 to Day 85, Part 2]
CL = Total body clearance of the drug
- Vz of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants [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
- CSF/serum UCB7853 concentration ratio on Day 7 (Part 1) [Day 7 (Part 1)]
CSF = Cerebrospinal fluid
- CSF/serum UCB7853 concentration ratio on Day 63 (Part 2) [Day 63 (Part 2)]
CSF = Cerebrospinal fluid
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Up0092 201 | Leiden | Netherlands | ||
| 2 | Up0092 101 | London | United Kingdom |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UP0092
- 2020-003356-32