The study will assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses of TD-0903 in healthy volunteers and will enroll up to 54 volunteers. Upon regulatory review and approval, the program will then initially move to a Phase II study in hospitalized patients with COVID-19 in the same clinical setting in the UK.
"Theravance Biopharma's efforts to address COVID-19 leverage years of experience in developing lung-selective medicines to treat respiratory disease. We are pleased to have received expedited approval of TD-0903's CTA and are working to progress this potential treatment option through clinical trials as quickly as possible," said Rick E Winningham, Chief Executive Officer. "The clinical site that we are working with has a long history of evaluating our inhaled medicines, and we are proud to be working with them to advance TD-0903 into clinical testing."