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The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.
This is a randomized, double-blind, Phase 1 study designed to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants. The study will enroll participants in SC and IV cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC injection of cizutamig | Experimental | cizutamig subcutaneous injection |
|
| SC injection of placebo | Placebo Comparator | placebo subcutaneous injection |
|
| IV infusion of cizutamig | Experimental | IV cizutamig |
|
| IV infusion of placebo | Placebo Comparator | IV placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cizutamig | Biological | cizutamig will be dosed SC or IV according to the assigned cohort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events through end of study | Baseline to 8 weeks | |
| PK parameters for cizutamig: AUC and dose-normalized AUC | Baseline to 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| Placebo | Other | placebo will be dosed IV or SC according to the assigned cohort |
|
| PK parameters for cizutamig: Cmax and dose-normalized Cmax |
| Baseline to 8 Weeks |
| PK parameter for cizutamig: Tmax | Baseline to 8 Weeks |
| PK parameter for cizutamig: t½ | Baseline to 8 weeks |
| PK Parameters for cizutamig: CL | IV only | Baseline to 8 Weeks |
| PK Parameters for cizutamig: CL/F | SC only | Baseline to 8 weeks |
| Anti-drug antibodies (ADAs) | Baseline to 8 weeks |
| Changes in body temperature | oral, tympanic, or axillary | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: QRS interval | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: PR interval | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: QTcB | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: QTcF | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: QT interval | Baseline to 8 Weeks |
| Changes in ECG parameters from baseline through end of study: RR | Baseline to 8 Weeks |
| Changes from baseline in safety laboratory assessments through end of study: serum chemistry | Baseline to 8 Weeks |
| PK Parameters for cizutamig: Vz | IV only | Baseline to 8 weeks |
| PK Parameters for cizutamig: Vss | IV only | Baseline to 8 weeks |
| PK Parameters for cizutamig: Vz/F | SC only | Baseline to 8 Weeks |
| Changes in heart rate | Baseline to 8 weeks |
| Changes in respiratory rate | Baseline to 8 weeks |
| Changes in blood pressure | systolic and diastolic | Baseline to 8 weeks |
| Changes in pulse oximetry | Baseline to 8 weeks |
| Changes from baseline in Red Blood Cell count | Baseline to 8 weeks |
| Changes from baseline in White Blood Cell count | Baseline to 8 weeks |
| Changes from baseline in Platelets | Baseline to 8 weeks |
| Changes from baseline in Hematocrit | Baseline to 8 weeks |
| Changes from baseline in Hemoglobin | Baseline to 8 weeks |