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Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX-105 Infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX-105 | Drug | Sterile solution for intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| PRX-105 plasma concentration | Assessment of pharmacokinetics | 0 to 48 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular monitoring | Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation. | 0 to 48 hours after injection |
| Neurological examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Einat Almon, PhD | Protalix Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000602637 | PRX-105 |
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Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking
| 0 to 48 hours |
| Ophthalmic evaluation | pupillar light reaction, accommodation, visual acuity | 0 to 8 hours |