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The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose of donzakimig in Chinese participants | Experimental | Chinese participants will be randomized to receive a predefined dosage of donzakimig. |
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| High Dose of donzakimig in Chinese participants | Experimental | Chinese participants will be randomized to receive a predefined dosage of donzakimig. |
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| Low Dose of placebo in Chinese participants | Placebo Comparator | Chinese participants will be randomized to receive a predefined dosage of placebo. |
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| High Dose of placebo in Chinese participants | Placebo Comparator | Chinese participants will be randomized to receive a predefined dosage of placebo. |
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| Low Dose of donzakimig in Japanese participants | Experimental | Japanese participants will be randomized to receive a predefined dosage of donzakimig. |
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| High Dose of donzakimig in Japanese participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donzakimig | Drug | Drug: Donzakimig Pharmaceutical form: Subcutaneous solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-emergent adverse events (TEAEs) | 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. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency | From Baseline to End of Study visit (up to Day 57) |
| Occurrence of serious treatment-emergent adverse events (serious TEAEs) | A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events | From Baseline to End of Study visit (up to Day 57) |
| Maximum plasma concentration (Cmax) of donzakimig | Cmax: Maximum plasma concentration of donzakimig | Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration. |
| Area under the plasma concentration-time curve from time 0 to t of donzakimig | AUC0-t: Area under the plasma concentration-time curve from from 0 to the time (t) of the last quantifiable concentration. | Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration. |
| Area under the plasma concentration-time curve from zero to infinity of donzakimig |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 0018445992273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0142 1 | Anaheim | California | 92801 | United States |
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 cannot be shared.
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| Experimental |
Japanese participants will be randomized to receive a predefined dosage of donzakimig. |
|
| Low Dose of placebo in Japanese participants | Placebo Comparator | Japanese participants will be randomized to receive a predefined dosage of placebo. |
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| High Dose of placebo in Japanese participants | Placebo Comparator | Japanese participants will be randomized to receive a predefined dosage of placebo. |
|
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| Placebo | Drug | Drug: Placebo Pharmaceutical form: Subcutaneous solution |
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AUC: Area under the plasma concentration-time curve from zero to infinity of donzakimig
| Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration. |