A Phase 1 interventional study of Nezulcitinib (TD-0903) Dose A and Nezulcitinib (TD-0903) Dose B in Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19), sponsored by Theravance Biopharma. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by Theravance Biopharma · Phase 1, Interventional, and Treatment
This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.
A Phase 1, open-label, fixed-sequence, 4-period study to evaluate the plasma PK, safety and tolerability of single inhaled doses of nezulcitinib (TD-0903) administered under different supplemental oxygenation scenarios in healthy participants.
Approximately 14 healthy adult male and female participants will receive a single inhaled dose of nezulcitinib using a nebulizer device on Day 1 of each administration period, under different supplementary oxygenations conditions.
Administration A: Dose A nezulcitinib delivered by nasal inhalation via the Aerogen Solo with a high-flow nasal cannula circuit delivering supplemental oxygen, Administration B: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a low-flow nasal cannula delivering supplemental oxygen, Administration C: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a high-flow nasal cannula delivering supplemental oxygen, Administration D: Nezulcitinib delivered by inhalation. Route to be determined based on data from administration A-C.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Nezulcitinib (TD-0903) Dose A
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
Drug: Nezulcitinib (TD-0903) Dose A
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
Drug: Nezulcitinib (TD-0903) Dose A
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.
Drug: Nezulcitinib (TD-0903) Dose B
TD-0903 Dose A
TD-0903 Dose B
AUC0-inf
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
AUC0-t
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Cmax
Maximum observed concentration (Cmax) of TD-0903 in plasma
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Adverse Events
Number and severity of treatment emergent adverse events
Time frame: Day 1 through 7 following dosing on Day 1 in each of 4 Periods
Plan to share: No — Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Theravance Biopharma