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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB825 | Experimental | 6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB825 | Drug | FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse events (AE) | Up to day140 | |
| Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis) | Up to day140 | |
| Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature) | Up to day140 | |
| 12-lead ECG results | Up to day140 | |
| Physical examination findings | Up to day140 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of PK parameters | Blood will be collected for the determination of serum FB825 concentrations, Cmax, Tmax, AUC, and terminal half-life.These parameters will be determined using non-compartmental methods. | Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose |
| Total IgE serum concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo |
| Drug |
Solution containing no active ingredients |
|
Blood will be collected to measure serum IgE concentrations. |
| pre-dose, 5, 14, 29, 85, and 140 day post-dose |
| Immunogenicity (Anti-FB825 antibody in serum) | Blood will be collected to measure Immunogenicity. | pre-dose, 5, 14, 29, 85, and 140 day post-dose |