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The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lpathomab | Experimental | 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab, |
|
| Placebo | Placebo Comparator | Saline solution for intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg/kg Lpathomab | Biological |
| ||
| 1.0 mg/kg Lpathomab |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with local or systemic Adverse Events | 85 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dario A Paggiarino, MD | Lpath, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Salt Lake City | Utah | 84106 | United States |
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|
| 3.0 mg/kg Lpathomab | Biological |
|
| 10 mg/kg Lpathomab | Biological |
|
| 20 mg/kg Lpathomab | Biological |
|
| Saline solution for intravenous infusion | Other |
|
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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