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.
Drug: TD-0903
Study drug to be administered by inhalation
Drug: Placebo
Placebo to be administered by inhalation
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
Theravance Biopharma Investigational Site
Manchester, United Kingdom
Medical Monitor, Study Director
Theravance Biopharma