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It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.
Objectives are to determine:
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levodopa and carbidopa | Placebo Comparator |
| |
| Placebo | Placebo Comparator | Saline solution for subcutaneous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND0612 | Drug | levodopa and carbidopa solution for subcutaneous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
| 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoseph Caraco, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Drug |
Saline solution for SC continuous administration |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |