Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the safety and tolerability after administration of multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in healthy study participants and participants with Parkinson's Disease (PD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - UCB0599 | Experimental | Participants will be randomized to receive a predefined dosage of UCB0599. |
|
| Cohort 2 - UCB0599 | Experimental | Participants will be randomized to receive a predefined dosage of UCB0599. |
|
| Cohort 1 - Placebo | Placebo Comparator | Participants will be randomized to receive a predefined dosage of Placebo. |
|
| Cohort 2 - Placebo | Placebo Comparator | Participants will be randomized to receive a predefined dosage of Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0599 | Drug | Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Avents (TEAEs) from Baseline to End of Study visit | 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. | From Baseline to End of study visit (up to Week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) in healthy participants on Day 1 | Cmax: Maximum observed plasma concentration | Day 1: Predose up to 12 hours post dose |
| Maximum observed plasma concentration (Cmax) in healthy participants on Day 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0077 102 | Long Beach | California | 90806 | United States | ||
| Up0077 103 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38110790 | Derived | Mercier J, Bani M, Colson AO, Germani M, Lalla M, Plisson C, Huiban M, Searle G, Mathy FX, Nicholl R, Otoul C, Smit JW, van Asch V, Wagneur M, Maguire RP. Evaluation and Application of a PET Tracer in Preclinical and Phase 1 Studies to Determine the Brain Biodistribution of Minzasolmin (UCB0599). Mol Imaging Biol. 2024 Apr;26(2):310-321. doi: 10.1007/s11307-023-01878-7. Epub 2023 Dec 18. | |
| 35959805 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding. |
|
Cmax: Maximum observed plasma concentration
| Day 28: Predose up to 24 hours post dose |
| Time to maximum observed plasma concentration (tmax) in healthy participants on Day 1 | Tmax: Time of observed Cmax | Day 1: Predose up to 12 hours post dose |
| Time to maximum observed plasma concentration (tmax) in healthy participants on Day 28 | Tmax: Time of observed Cmax | Day 28: Predose up to 24 hours post dose |
| Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in healthy participants on Day 1 | AUC(0-12h): Area under the curve from time 0 to 12 hours | Day 1: Predose up to 12 hours post dose |
| Area under the concentration-time curve for the dosing interval (AUCtau) in healthy participants on Day 28 | AUCtau: Area under the concentration-time curve for the dosing interval at steady state | Day 28: Predose up to 24 hours post dose |
| Maximum observed plasma concentration (Cmax) in patients on Day 1 | Cmax: Maximum observed plasma concentration | Day 1: Predose up to 12 hours post dose |
| Maximum observed plasma concentration (Cmax) in patients on Day 28 | Cmax: Maximum observed plasma concentration | Day 28: Predose up to 24 hours post dose |
| Time to maximum observed plasma concentration (tmax) in patients on Day 1 | Tmax: Time of observed Cmax | Day 1: Predose up to 12 hours post dose |
| Time to maximum observed plasma concentration (tmax) in patients on Day 28 | Tmax: Time of observed Cmax | Day 28: Predose up to 24 hours post dose |
| Area under the concentration - time curve (AUC(0-12h)) from time 0 to 12 hours in patients on Day 1 | AUC(0-12h): Area under the curve from time 0 to 12 hours | Day 1: Predose up to 12 hours post dose |
| Area under the concentration-time curve for the dosing interval (AUCtau) in patients on Day 28 | AUCtau: Area under the concentration-time curve for the dosing interval at steady state | Day 28: Predose up to 24 hours post dose |
| Bay Harbor Islands |
| Florida |
| 33154 |
| United States |
| Up0077 105 | DeLand | Florida | 32720 | United States |
| Up0077 107 | Atlanta | Georgia | 30331 | United States |
| Up0077 101 | Farmington Hills | Michigan | 48334 | United States |
| Up0077 104 | Raleigh | North Carolina | 27612 | United States |
| Derived |
| Smit JW, Basile P, Prato MK, Detalle L, Mathy FX, Schmidt A, Lalla M, Germani M, Domange C, Biere AL, Bani M, Carson S, Genius J. Phase 1/1b Studies of UCB0599, an Oral Inhibitor of alpha-Synuclein Misfolding, Including a Randomized Study in Parkinson's Disease. Mov Disord. 2022 Oct;37(10):2045-2056. doi: 10.1002/mds.29170. Epub 2022 Aug 12. |
| 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 |
Not provided
Not provided