Phase 2Active, not recruitingAge-related condition
Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary Fibrosis
- Sponsor
- Redx Pharma Ltd (Industry)
- Enrolment
- 48 enrolled
- Conditions
- IPF; Fibrosis
- Interventions
- RXC007; Placebo
- Ages
- adults, older adults
- Registry
- NCT05570058
Full record on ClinicalTrials.gov
From the registry
The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or pirfenidone.
Primary outcomes
- Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs
- Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
- Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to 12 weeks of treatment
- Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) from first dose on Day 1 up to completion of the post-study visit.
History
Study completion
Last registry update
Primary completion
Registered
Started