First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

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.

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