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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000772-26 | EudraCT Number |
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This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose placebo comparator for each active arm |
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| UCB4019 Dose 1 | Experimental | Dose 1 calculated based on body weight |
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| UCB4019 Dose 2 | Experimental | Dose 2 calculated based on body weight |
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| UCB4019 Dose 3 | Experimental | Dose 3 calculated based on body weight |
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| UCB4019 Dose 4 | Experimental | Dose 4 calculated based on body weight |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PR1 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events during the study | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. | Day 1 up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 | |
| Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 887 822 9493) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0028 001 | London | United Kingdom |
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| PL1 | Other |
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| Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 |
| Time to reach Cmax (Tmax) | Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7 | Predose (Day 1), Day 7 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10 | Predose (Day 1), Day 10 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13 | Predose (Day 1), Day 13 |