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| Name | Class |
|---|---|
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
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This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOD-4023, dose level 1 | Experimental |
| |
| MOD-4023, dose level 2 | Experimental |
| |
| MOD-4023, dose level 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOD-4023 (long lasting hGH) | Drug | Single subcutaneous dose of MOD-4023 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction) | 30 days | |
| Pharmacokinetics: AUC, Cmax, Tmax, T1/2 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Formation of anti-drug antibodies | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Atsmon, M.D. | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| C000634267 | MOD-4023 |
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| Placebo | Drug | Single subcutaneous dose of placebo material |
|