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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose study design in healthy volunteers.
L606 (Liposomal Treprostinil) Inhalation Solution and dedicated inhalation system is developed by Pharmosa Biopharm Inc. intended to improve the inconvenience, as one of the greatest impediments to patient satisfaction to current inhaled treprostinil therapy. Pharmosa's liposomal technology offers sustained release of treprostinil which enable bid treatment instead of conventional qid treatment offered by current inhaled treprostinil therapy for treatment of patients with PAH (WHO Group 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo group |
|
| L606 Liposomal inhalation solution | Experimental | Liposomal inhalation solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L606 (Liposomal Treprostinil) Inhalation Solution 51ug | Drug | Single ascending dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of treatment-emergent adverse events for L606 and placebo, including abnormal laboratory events | Frequency, severity and seriousness of adverse events (AE) including physical examination, incident of laboratory abnormalities, 12-lead ECG parameter and vital sign assessment | From Pre-dose to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-2hr | area under curve from time zero to 2 hours postdose | From pre-dose to 24 hours post dose |
| AUC0-4hr | AUC from time zero to 4 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas L Hunt, MD, PhD | Pharmosa Biopharm Inc.PPD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| L606 Inhalation System | Device | Single ascending dose |
|
|
| Placebo Solution | Other | Single ascending dose |
|
| From pre-dose to 24 hours post dose |
| AUC0-8hr | area under curve from time zero to 8 hours postdose | From pre-dose to 24 hours post dose |
| AUC0-12hr | area under curve from time zero to 12 hours postdose | From pre-dose to 24 hours post dose |
| AUC0-24hr | area under curve from time zero to 24 hours postdose | From pre-dose to 24 hours post dose |
| AUC0-tlast | AUC from time zero to the time of the last quantifiable concentration | From pre-dose to 24 hours post dose |
| AUC0-∞ | area under curve from time zero to infinite | From pre-dose to 24 hours post dose |
| Cmax | maximum plasma concentration | From pre-dose to 24 hours post dose |
| tmax | time to Maximum Plasma Concentration | From pre-dose to 24 hours post dose |
| t1/2 | time to half-life | From pre-dose to 24 hours post dose |
| CL/F | apparent total plasma clearance | From pre-dose to 24 hours post dose |
| Vz/F | apparent volume of distribution during terminal phase | From pre-dose to 24 hours post dose |