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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
TD-0903 Dose A
TD-0903 Dose B
Theravance Biopharma Investigational Site
Cypress, California, United States
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
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