Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)Phase 1NCT05091723
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
A Phase 1 study testing Nezulcitinib (TD-0903) Dose A and Nezulcitinib (TD-0903) Dose B in people with Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19), run by Theravance Biopharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)
- What is being tested?
- Nezulcitinib (TD-0903) Dose A and Nezulcitinib (TD-0903) Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 24 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Theravance Biopharma Investigational Site
Cypress, California, 90630
About this study
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
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.
Read the 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.
- Being tested
- Nezulcitinib (TD-0903) Dose A, Nezulcitinib (TD-0903) Dose B
- Keywords
- Acute lung injury, ALI, Coronavirus Disease-2019, COVID-19, Supplemental oxygen
- Medical subject headings
- Acute Lung Injury, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nezulcitinib (TD-0903) Dose ADrug
TD-0903 Dose A
Nezulcitinib (TD-0903) Dose BDrug
TD-0903 Dose B
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nezulcitinib (TD-0903) Dose A |
| 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 Receives: Drug: Nezulcitinib (TD-0903) Dose A |
| 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 Receives: Drug: Nezulcitinib (TD-0903) Dose A |
| 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. Receives: Drug: Nezulcitinib (TD-0903) Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
Measured: 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
Measured: 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
Measured: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Secondary outcomes (1)
Adverse Events
Number and severity of treatment emergent adverse events
Measured: Day 1 through 7 following dosing on Day 1 in each of 4 Periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start13 Oct 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091723
- Sponsor's protocol ID
- 0196
- Status last verified
- Dec 2021
- First submitted
- 12 Oct 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05091723
- Acronym / sponsor ID
- 0196
- Keywords
- Acute lung injury, ALI, Coronavirus Disease-2019, COVID-19, Supplemental oxygen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Administration Scenario A | Experimental | Drug: Nezulcitinib (TD-0903) Dose ASingle 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 | Drug: Nezulcitinib (TD-0903) Dose ASingle 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 | Drug: Nezulcitinib (TD-0903) Dose ASingle 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 | Drug: Nezulcitinib (TD-0903) Dose BSingle 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nezulcitinib (TD-0903) Dose ATD-0903 Dose A | Drug | Administration Scenario A, Administration Scenario B, Administration Scenario C |
| Nezulcitinib (TD-0903) Dose BTD-0903 Dose B | Drug | Administration Scenario D |
Primary outcome
AUC0-inf
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
The area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) of TD-0903
AUC0-t
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
The area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-0903
Cmax
Time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period
Maximum observed concentration (Cmax) of TD-0903 in plasma
1 secondary outcome
Adverse Events
Time frame: Day 1 through 7 following dosing on Day 1 in each of 4 Periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nezulcitinib (TD-0903) Dose A and Nezulcitinib (TD-0903) Dose B in people with Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19), run by Theravance Biopharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: Predose and at prespecified time points up to 48 hours after dosing on Day 1 of each period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.