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 being evaluated for the treatment of acute lung injury (ALI) due to Coronavirus Disease-2019 (COVID-19). It is an investigational small molecule developed by Theravance Biopharma, Inc. and has been studied in a Phase 1 clinical trial.
Nezulcitinib Dose A targets JAK3, JAK1, JAK2, and TYK2, which are Janus kinase family enzymes. It acts as an inhibitor of these targets. This mechanism is intended to modulate inflammatory signaling pathways relevant to acute lung injury.
Nezulcitinib Dose A is being developed by Theravance Biopharma, Inc., which trades under the ticker symbol TBPH. The company is responsible for the clinical development of this investigational therapy.
Nezulcitinib Dose A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed.
Nezulcitinib Dose A has been studied in one completed Phase 1 clinical trial, NCT05091723, titled "TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation." The trial enrolled 14 healthy participants in the United States.
Yes, Nezulcitinib Dose A is also known as Nezulcitinib (TD-0903) Dose A. TD-0903 is an alternative identifier for the same investigational compound. Both names refer to the same drug candidate developed by Theravance Biopharma.