Single and Multiple Ascending Dose Study of Inhaled TD-0903 [COVID-19]
Research type
Research Study
Full title
A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TD-0903, a Potential Treatment for Acute Lung Injury Associated with COVID-19.
IRAS ID
279978
Contact name
Dave Singh
Contact email
Sponsor organisation
Theravance Biopharma Ireland Limited
Eudract number
2020-000577-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
TD-0903 is a potential new drug being developed for the purpose of treating acute lung injury associated with Corona Virus Disease 2019 (COVID-19) and other inflammatory lung conditions.\n\nInflammation is a key feature of numerous inflammatory lung conditions such as post-transplant rejection, cystic fibrosis etc. There is emerging evidence in the current coronavirus disease 2019 (COVID-19) clinical experience that a subgroup of patients might have a hyperinflammatory syndrome resulting in acute lung injury and acute respiratory distress syndrome. This hyperinflammatory response can potentially be modulated and treated by a pan-JAK inhibitor. \n\nA nebulized pan-JAK inhibitor may be a valuable therapeutic agent in patients with respiratory distress to avoid progression of the disease to require ventilatory support, or to reduce mortality in those patients requiring ventilatory support.\n\nTD-0903 is a lung-selective pan-JAK inhibitor specifically designed for inhaled delivery and lung-restricted distribution, to ensure maximal activity at the site of inflammation while minimizing systemic activity.\n\nThis is the first study with TD-0903 in humans, and is designed to evaluate the safety, tolerability, and PK following single ascending doses (Part A) and multiple ascending doses (Part B) in healthy subjects. A randomized, double-blind, placebo-controlled design has been selected to allow for unbiased analysis of safety and tolerability data. The study will be conducted in a dose escalation format in order to characterize doses (up to 10 mg in Part A and 10 mg/day in Parts B) that are anticipated to be safe and efficacious in the treatment of acute lung injury related to COVID-19, as well as other inflammatory lung diseases. Dose escalation will be based on safety, tolerability, and available PK data from previous cohorts.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0123
Date of REC Opinion
7 Apr 2020
REC opinion
Favourable Opinion