Acute Lung Injury (ALI) Associated With COVID-19Phase 1NCT04350736
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
A Phase 1 study testing TD-0903 in people with Acute Lung Injury (ALI) Associated With COVID-19 and Inflammatory Lung Conditions Associated With COVID-19, run by Theravance Biopharma at 1 site in United Kingdom.
Trial summary
This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19
- What is being tested?
- TD-0903
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2020to 1 Jul 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weighs at least 50 kg.
- Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs.
- Forced expiratory volume in 1 second (FEV1) ≥80%.
- No clinically significant abnormalities in the results of laboratory evaluations.
- 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, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential.
- Understands the correct technique for the use the nebulizer device(s).
- 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.
- Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening.
- Positive test for SARS-CoV-2
- Subject has any condition of the oro-laryngeal or respiratory tract.
- Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
- Additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Theravance Biopharma Investigational Site
Manchester, M23 9QZ
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
- Conditions
- Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19
- Being tested
- TD-0903, Placebo
- Keywords
- Acute lung injury, ALI, COVID-19, Coronavirus Disease 2019, inflammatory lung conditions, Inflammatory lung disease
- 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.
TD-0903Drug
Study drug to be administered by inhalation
PlaceboDrug
Placebo to be administered by inhalation
| Study group | Role | What they receive |
|---|---|---|
| TD-0903 for SAD (Part A) | Experimental | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 Receives: Drug: TD-0903 |
| Placebo for SAD (Part A) | Experimental | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo Receives: Drug: Placebo |
| TD-0903 for MAD (Part B) | Experimental | 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 Receives: Drug: TD-0903 |
| Placebo for MAD (Part B) | Experimental | 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of SAD of TD-0903: Adverse Events
Number and severity of treatment emergent adverse events
Measured: Day 1 to Day 8
Safety and Tolerability of MAD of TD-0903: Adverse Events
Number and severity of treatment emergent adverse events
Measured: Day 1 to Day 14
Secondary outcomes (6)
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Measured: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Measured: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Measured: Day 1 through Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start23 Apr 2020
- Primary completion24 Jun 2020
- Study completion1 Jul 2020
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) Associated With COVID-19Studies 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
- Randomised
- Intervention model
- Sequential
- Model description
- double-blind, randomized, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 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
- NCT04350736
- Sponsor's protocol ID
- 0183
- Other IDs
- 2020-000577-24
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
- ClinicalTrials.gov ID
- NCT04350736
- Acronym / sponsor ID
- 0183
- Conditions
- Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19
- Keywords
- Acute lung injury, ALI, COVID-19, Coronavirus Disease 2019, inflammatory lung conditions, Inflammatory lung disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Apr 2020 (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 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- double-blind, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| TD-0903 for SAD (Part A) | Experimental | Drug: TD-09036 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for SAD (Part A) | Experimental | Drug: Placebo2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
| TD-0903 for MAD (Part B) | Experimental | Drug: TD-09038 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
| Placebo for MAD (Part B) | Experimental | Drug: Placebo2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weighs at least 50 kg.
- Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs.
- Forced expiratory volume in 1 second (FEV1) ≥80%.
- No clinically significant abnormalities in the results of laboratory evaluations.
- 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 (8 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.
- Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening.
- Positive test for SARS-CoV-2
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 |
|---|---|---|
| TD-0903Study drug to be administered by inhalation | Drug | TD-0903 for MAD (Part B), TD-0903 for SAD (Part A) |
| PlaceboPlacebo to be administered by inhalation | Drug | Placebo for MAD (Part B), Placebo for SAD (Part A) |
Primary outcome
Safety and Tolerability of SAD of TD-0903: Adverse Events
Time frame: Day 1 to Day 8
Number and severity of treatment emergent adverse events
Safety and Tolerability of MAD of TD-0903: Adverse Events
Time frame: Day 1 to Day 14
Number and severity of treatment emergent adverse events
6 secondary outcomes
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax
Time frame: Day 1 through Day 9
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 1 Jul 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 TD-0903 in people with Acute Lung Injury (ALI) Associated With COVID-19 and Inflammatory Lung Conditions Associated With COVID-19, run by Theravance Biopharma at 1 site in United Kingdom.
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 8 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 1 Jul 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 Kingdom. 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?
Safety and Tolerability of SAD of TD-0903: Adverse Events (time frame: Day 1 to Day 8). The study lists 2 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 1 Jul 2021.