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: This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days. Subjects will remain at the clinical center for 24 hours after the first administration (Day 1) of OPRX-106 including PK sampling and then return to the site daily for additional administrations and study procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg | Experimental | OPRX-106 2 mg oral once daily for 5 days |
|
| 8 mg | Experimental | OPRX-106 8 mg oral once daily for 5 days |
|
| 16 mg | Experimental | OPRX-106 16 mg oral once daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPRX-106 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events from subject reporting or other assessments | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Einat Almon, PdH | Protalix Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |