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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004411-26 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of zampilimab in healthy study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zampilimab Cohorts | Experimental | Participants will be randomized to receive predefined single doses of zampilimab. |
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| Placebo | Placebo Comparator | Participants randomized to this arm will receive matching Placebo to maintain the blinding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zampilimab | Drug | Participants will receive a single intravenous dose of zampilimab at a pre-specified time point. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidents of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit | A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment. | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Maximum intensity of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit | Maximum intensity across all incidents of each TEAE for each study participant | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum zampilimab serum concentration (Cmax) | Cmax: Maximum observed zampilimab serum concentration | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Time to maximum zampilimab serum concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0105 001 | 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 cannot be shared.
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This is a participant- and Investigator-blind study.
| Placebo | Drug | Participants will receive matching placebo at a pre-specified time point to maintain the blinding. |
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tmax: Time to maximum observed zampilimab serum concentration
| From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Area under the zampilimab serum concentration-time curve from time zero to last quantifiable concentration (AUC0-t) | AUC0-t: Area under the zampilimab serum concentration-time curve from time zero (Day 1) to the last quantifiable concentration | From Day 1 (Start of Treatment Period) at predefined time points to the last quantifiable concentration (up to 120 days) |
| Area under the zampilimab serum concentration-time curve from time zero to infinity (AUC) | AUC: Area under the zampilimab serum concentration-time curve from time 0 (Day 1) to infinity | Day 1 (Start of Treatment Period) at predefined time points (up to 120 days) |
| Clearance (CL) of zampilimab in serum | CL: volume of serum that is cleared from zampilimab per unit of time | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Apparent volume of distribution during terminal phase (Vz) of zampilimab | Vz: apparent volume of distribution during terminal phase | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |
| Apparent terminal half-life (t1/2) of zampilimab | t1/2: terminal zampilimab serum half-life | From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days) |