Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03464864 | Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers | PHASE1 | COMPLETED | 36 | — | — | Mar 9, 2018 | Jun 5, 2018 | Oct 30, 2018 | 1 | United States |
Incidence and severity of treatment-related adverse events determined by changes from screening (baseline) of findings from physical examinations, laboratory evaluations, vital signs measurements, pulmonary testing, and ECG measurements.
| Arm | Type | Description |
|---|---|---|
| Treprostinil Inhalation Powder 30 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 60 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 90 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 120 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 150 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 180 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 240 mcg | EXPERIMENTAL | - |
| Treprostinil Inhalation Powder 300 mcg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Treprostinil Inhalation Powder | DRUG | Single ascending dose |
Inclusion Criteria: 1. Voluntarily consents to participate in this study and provides written informed consent prior to the start of any study-specific procedures. 2. Male or female. Females must not be pregnant or breastfeeding. 3. Is between 18 and 55 years of age (inclusive). 4. Female subjects ...