Clinical trial NCT05091723: TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Official title: Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)
Keywords: Acute lung injury
ALI
Coronavirus Disease-2019
COVID-19
Supplemental oxygen
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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% predicted at screening and prior to dosing
* No clinically significant abnormalities in the results of laboratory
* Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method
* Male subjects must agree to use condoms to prevent potential fetal or partner exposure through seminal fluid, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential
* Able to understand the correct technique for the use of the nebulizer device
* Other inclusion criteria apply

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition
* Abnormal ECG measurements at screening
* Any signs of respiratory tract infection within 6 weeks of screening
* Has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to screening
* Has any condition of the oro-laryngeal or respiratory tract
* History or presence of alcoholism or drug abuse
* Positive urine drugs of abuse test
* Positive urine or breath alcohol results
* Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
* Tests positive for active COVID-19
* Additional exclusion criteria apply

Primary outcomes:
measure: AUC0-inf
timeFrame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
measure: AUC0-t
timeFrame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
measure: Cmax
timeFrame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Secondary outcomes:
measure: Adverse Events
timeFrame: Day 1 through 7 following dosing on Day 1 in each of 4 Periods
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Theravance Biopharma Investigational Site
state: California
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: