This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.
This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older. The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Halifax, Nova Scotia, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Sherbrooke, Quebec, Canada
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 4 months
Change from baseline on pulmonary function tests
Time frame: 3 months
Change from baseline in imaging of thorax
Time frame: 3 months
Change from baseline on biomarkers
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.