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Discontinued early due to local tolerance expectations not being met.
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To determine the maximum tolerated dose (MTD) and assess safety and tolerability of escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection to healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TransCon Treprostinil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransCon Treprostinil | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and tolerability of single doses of TransCon Treprostinil treatment | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] of TransCon Treprostinil | Pharmacokinetic profile of single doses of TransCon Treprostinil | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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