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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004485-34 | EudraCT Number |
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The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 2 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 3 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 1 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 2 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants | 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 until Safety Follow-up (up to Week 8) |
| Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Chinese study participants | 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 until Safety Follow-up (up to Week 8) |
| Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese study participants | Maximum observed plasma concentration (Cmax) | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Chinese study participants | Maximum observed plasma concentration (Cmax) | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0060 1 | London | United Kingdom |
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 will not be shared.
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| Dose 3 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 2 of rozanolixizumab in Chinese subjects | Experimental | Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Dose 3 of rozanolixizumab in Chinese subjects | Experimental | Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
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| Placebo in Japanese subjects | Placebo Comparator | Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
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| Placebo in Chinese subjects | Placebo Comparator | Chinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
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| Placebo in Caucasian subjects | Placebo Comparator | Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
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| Placebo | Drug |
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| Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese study participants |
Time of observed Cmax (tmax) |
| Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Chinese study participants | Time of observed Cmax (tmax) | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese study participants | AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Chinese study participants | AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| From Baseline until Safety Follow-up (up to Week 8) |
| AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab | AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| AUC(0-t)/D: Dose normalized AUC(0-t) | AUC(0-t)/D: Dose normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) | AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Cmax/BW: Body weight normalized Cmax of rozanolixizumab | Cmax/BW: Body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Cmax/D: Dose normalized Cmax | Cmax/D: Dose normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| Cmax/D/BW: Dose and body weight normalized Cmax | Cmax/D/BW: Dose and body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants | Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours |
| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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