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The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oshadi D | Experimental | 2 dose levels of Oshadi D in 2 food regimen will be administered as following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oshadi D | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keren Duanis, MD | Assaf Harofe Medical Center, Israel | Principal Investigator |
| Hanna Levy, Dr. | Oshadi Drug Administration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center, | Zrifin | Israel |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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