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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003111-10 | EudraCT Number |
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The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of UCB0022 and food effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0022 | Drug | Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B, C and D. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline (Day 1) to end of study Visit (up to Day 29 Part A) (up to Day 21 Part B and C) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
Part C only:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0091 1 | London | United Kingdom |
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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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.
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This is a participant- and investigator-blind study.
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| 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. |
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| 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. |
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| Placebo | Other | Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C. |
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tmax: time to maximum plasma concentration for each single dose of UCB0022 in Part A |
| 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 | 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 | 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 | 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 | 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 | From Day 1 (predose) at predefined time points to the last quantifiable concentration (Day 16) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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