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The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1. |
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| Cohort 2 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1. |
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| Cohort 3 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1. |
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| Cohort 4 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1. |
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| Cohort 5 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB5285 | Drug | Participants will receive UCB5285 as prespecified in each cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment emergent adverse events (TEAEs) are adverse events that are not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency. | From Day 1 to the End Of Study (up to Day 161) |
| Incidence of Treatment-Emergent Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:
| From Day 1 to the End Of Study (up to Day 161) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of UCB5285 | Maximum observed serum concentration (Cmax) of UCB5285 | From Day 1 (Predose) at predefined time points up to Day 161 |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC) of UCB5285 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com | |
| UCB Cares | Contact | 001 844 599 2273 |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0161 1001 | Recruiting | Harrow | United Kingdom |
Due to the small sample size in this trial, individual participant-level data cannot be adequately anonymized as 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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| Cohort 6 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1. |
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| Cohort 7 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2. |
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| Cohort 8 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1. |
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| Placebo | Other | Participants will receive matching placebo as prespecified in each cohort. |
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Area under the serum concentration-time curve from time zero to infinity (AUC) of UCB5285 |
| From Day 1 (Predose) at predefined time points up to Day 161 |
| Area Under the Serum Concentration-Time Curve from Time Zero to the Time of Last Detectable Concentration (AUC0-t) of UCB5285 | Area under the serum concentration-time curve from time zero to the time of last detectable concentration (AUC0-t) of UCB5285 | From Day 1 (Predose) at predefined time points up to Day 161 |