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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05091723 | TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation | PHASE1 | COMPLETED | 14 | — | — | Oct 13, 2021 | Nov 24, 2021 | Dec 10, 2021 | 1 | United States |
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Maximum observed concentration (Cmax) of TD-0903 in plasma
| Arm | Type | Description |
|---|---|---|
| Administration Scenario A | EXPERIMENTAL | Single dose of TD-0903 at Dose A on Day 1, Period 1 delivered by nasal inhalation via nebulizer device with a high-flow nasal cannula delivering supplemental oxygen |
| Administration Scenario B | EXPERIMENTAL | Single dose of TD-0903 at Dose A on Day 1, Period 2 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via low-flow nasal cannula |
| Administration Scenario C | EXPERIMENTAL | Single dose of TD-0903 at Dose A on Day 1, Period 3 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via high-flow nasal cannula |
| Administration Scenario D | EXPERIMENTAL | Single dose of TD-0903 at Dose B on Day 1, Period 4 delivered by a route to-be-determined based on data from Scenarios A, B and C. |
| Name | Type | Description |
|---|---|---|
| Nezulcitinib (TD-0903) Dose A | DRUG | TD-0903 Dose A |
| Nezulcitinib (TD-0903) Dose B | DRUG | TD-0903 Dose B |
Inclusion Criteria: * Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 and weighs at least 50 kg at screening * Medically healthy with no clinically significant medical history, physical examination, spirometry, laboratory profiles, vital signs or ECGs * Forced expiratory volume of 1 second (FEV1) ≥80...