Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nezulcitinib Dose A · 1 trial · 1 indication
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...
Nezulcitinib Dose A is an investigational small molecule being developed for Acute Lung Injury (ALI) due to Coronavirus Disease-2019 (COVID-19). It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in the respiratory therapeutic area.
Nezulcitinib Dose A is being developed by Theravance Biopharma, Inc., a company traded on the NASDAQ under the ticker symbol TBPH. The drug is currently in Phase 1 clinical development for Acute Lung Injury due to COVID-19.
Nezulcitinib Dose A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug remains under investigation for Acute Lung Injury due to COVID-19.
Nezulcitinib Dose A has one completed clinical trial, NCT05091723, titled 'TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation.' This Phase 1 study enrolled 14 participants in the United States and included healthy volunteers.
Yes, Nezulcitinib Dose A is associated with the compound TD-0903, as indicated by the clinical trial title. The Phase 1 study NCT05091723 evaluates the pharmacokinetics of TD-0903 in healthy participants with supplemental oxygenation.