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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003356-32 | EudraCT Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB7853 | Experimental | Part 1: Single intravenous infusion of UCB7853 Part 2: Multiple intravenous infusions of UCB7853 at pre-specified time-points |
|
| Placebo | Placebo Comparator | Part 1: Single intravenous infusion of Placebo Part 2: Multiple intravenous infusions of Placebo at pre-specified time-points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB7853 | Drug | Subjects will receive UCB7853 at pre-specified time-points. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Day 1 to the End of Study Visit (Day 197), Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of UCB7853 in serum after intravenous infusion of single ascending doses in healthy male participants | Cmax = Maximum observed concentration | 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 |
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Inclusion Criteria:
Part 1 (healthy participants):
Part 2 (participants with Parkinson's Disease):
Exclusion Criteria:
Part 1 (healthy participants):
Part 2 (participants with Parkinson's Disease):
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0092 201 | Leiden | Netherlands | ||||
| Up0092 101 |
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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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Other |
Subjects will receive Placebo at pre-specified time-points. |
|
Cmax = Maximum observed concentration |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 7 (Part 1) |
| CSF/serum UCB7853 concentration ratio on Day 63 (Part 2) | CSF = Cerebrospinal fluid | Day 63 (Part 2) |
| London |
| United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |