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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005469-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB7665 Intravenous 1 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. |
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| UCB7665 Intravenous 2 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. |
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| UCB7665 Intravenous 3 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. |
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| UCB7665 Intravenous 4 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. |
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| UCB7665 Intravenous 5 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. |
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| UCB7665 Subcutaneous 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB7665 Intravenous 1 | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events during the study | Day -1 up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 001 | Harrow | Middlesex | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29093180 | Derived | Kiessling P, Lledo-Garcia R, Watanabe S, Langdon G, Tran D, Bari M, Christodoulou L, Jones E, Price G, Smith B, Brennan F, White I, Jolles S. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017 Nov 1;9(414):eaan1208. doi: 10.1126/scitranslmed.aan1208. |
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Single dose calculated based on body weight for 60 minutes subcutaneous infusion. |
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| UCB7665 Subcutaneous 2 | Experimental | Single dose calculated based on body weight for 60 minutes subcutaneous infusion. |
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| Intravenous Placebo | Placebo Comparator | Single dose placebo comparator for each active arm of intravenous infusion. |
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| Subcutaneous Placebo | Placebo Comparator | Single dose placebo comparator for each active arm of subcutaneous infusion. |
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| UCB7665 Intravenous 2 | Biological |
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| UCB7665 Intravenous 3 | Biological |
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| UCB7665 Intravenous 4 | Biological |
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| UCB7665 Intravenous 5 | Biological |
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| UCB7665 Subcutaneous 1 | Biological |
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| UCB7665 Subcutaneous 2 | Biological |
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| Intravenous Placebo | Biological |
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| Subcutaneous Placebo | Biological |
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| Area under the curve from 0 to infinity (AUC) | AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)] | AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Time to reach Cmax (Tmax) | Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Total Immunoglobulin G (IgG ) concentrations | Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Immunoglobulin G1 subclass concentrations | Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Immunoglobulin G2 subclass concentrations | Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Immunoglobulin G3 subclass concentrations | Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |
| Immunoglobulin G4 subclass concentrations | Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85. | Predose (Day 1) up to Day 85 |