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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06193031 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Nov 17, 2015 | Dec 18, 2015 | Jan 5, 2024 | 1 | United States |
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo | EXPERIMENTAL | Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1. |
| Cohort 2: C16TR Dose B or Placebo | EXPERIMENTAL | Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2. |
| Cohort 3: C16TR Dose C or Placebo | EXPERIMENTAL | Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3. |
| Name | Type | Description |
|---|---|---|
| C16TR | DRUG | Administered as inhalation using a Philips Micro device inhaler. |
| Placebo | DRUG | Phosphate buffered saline (PBS) administered using Philips Micro device inhaler. |
| Tyvaso® | DRUG | Administered as inhalation. |
Inclusion Criteria: * Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive, at screening. * Have a medical history, physical examination, vital signs, electr...