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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001129-15 | EudraCT Number |
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This study is designed to evaluate the safety and tolerability of UCB7858 when given as single ascending doses administered by intravenous or subcutaneous infusion in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB7858 (intravenous) | Experimental | Various single doses, administered to various cohorts. |
|
| Placebo (intravenous) | Placebo Comparator | Single dose placebo comparator for each cohort of iv administration. |
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| UCB7858 (subcutaneous) | Experimental | Various single doses, administered to various cohorts. |
|
| Placebo (subcutaneous) | Placebo Comparator | Single dose placebo comparator for each cohort of sc administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB7858 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events following administration of UCB7858 | Cohort 1-10: Day 1 up to Day 72 Cohort 11: Day 1 up to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 | |
| Time to reach Cmax (tmax) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
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Inclusion Criteria:
Exclusion Criteria:
For subjects enrolled in the cohorts where the skin biopsies will be performed (Cohort 7 onward), the following exclusion criteria will also apply:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0029 001 | London | United Kingdom |
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and 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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| Drug |
|
| Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)] | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Area under the curve from 0 to infinity (AUC) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| The terminal plasma half-life (t1/2) following intravenous administration | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Plasma clearance (CL) of UCB7858 following intravenous administration | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Volume of distribution (Vss) for UCB7858 at steady state following intravenous administration | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Apparent volume of distribution (Vss/F) of UCB7858 following subcutaneous administration | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Apparent plasma clearance (CL/F) of UCB7858 following subcutaneous administration | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Mean absolute bioavailability (F) of UCB7858 given subcutaneously, using the ratio of geometric mean AUCs for subcutaneous (sc) administration and intravenous (iv) infusion (AUC_sc/AUC_iv) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Concentration of UCB7858 at the end of infusion (Cinf) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |
| Time at the end of infusion of UCB7858 (tinf) | Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120 |