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
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.

Completed
Acute Lung Injury (ALI) Associated With COVID-19
Inflammatory Lung Conditions Associated With COVID-19

Drug: TD-0903

Study drug to be administered by inhalation

Drug: Placebo

Placebo to be administered by inhalation

Eligibility Criteria

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 exclusion criteria apply

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
United Kingdom
Locations

Theravance Biopharma Investigational Site
Manchester, United Kingdom

Medical Monitor, Study Director
Theravance Biopharma

Theravance Biopharma
NCT Number
Keywords
Acute Lung Injury
ALI
Covid-19
Coronavirus disease 2019
inflammatory lung conditions
Inflammatory lung disease
MeSH Terms
COVID-19
Lung Injury
Acute Lung Injury