CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis - Phase 1|Phase 2 - Recruiting

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment

Participants

Cystic Fibrosis|Pseudomonas Aeruginosa|Pseudomonas|Lung Infection|Lung Infection Pseudomonal - 18 Years and older   (Adult, Older Adult)

Interventions

Biological: AP-PA02|Other: Placebo

Outcome measures

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) of single and multiple doses of AP-PA02 administered by inhalation|Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation

Keywords: AP-PA02; Phage therapy; Anti-bacterial agents; pharmacological_intervention; Bacterial Infections; Infection; Inhalation OR nebulised; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections;