Acute Lung Injury (ALI) Associated With COVID-19, Inflammatory Lung Conditions Associated With COVID-19
Conditions
Keywords
Acute lung injury, ALI, COVID-19, Coronavirus Disease 2019, inflammatory lung conditions, Inflammatory lung disease
Brief 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.
Interventions
DRUGTD-0903
Study drug to be administered by inhalation
DRUGPlacebo
Placebo to be administered by inhalation
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
double-blind, randomized, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of SAD of TD-0903: Adverse Events | Day 1 to Day 8 | Number and severity of treatment emergent adverse events |
| Safety and Tolerability of MAD of TD-0903: Adverse Events | Day 1 to Day 14 | Number and severity of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax | Day 1 through Day 4 | 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) |
| Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC | Day 1 through Day 9 | 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) |
| Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC | Day 1 through Day 4 | 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) |
| Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax | Day 1 through Day 9 | 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) |
| Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax | Day 1 through Day 9 | Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax) |
| Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax | Day 1 through Day 4 | Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax) |
Countries
United Kingdom
Outcome results
None listed