SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects (NCT03669614) | Clinical Trial Compass
UnknownPhase 1/2
SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
United States102 participantsStarted 2018-12-07
Plain-language summary
This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P. aeruginosa infected cystic fibrosis (CF) subjects. Phase 1 of the study in HV subjects will consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design. The study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects.
Who can participate
Age range18 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent given by the subject.
✓. At least ≥ 18 years old and \< 50 years of age.
✓. Healthy with no acute medical condition for ≥ 2 weeks prior to screening and no known chronic medical condition requiring regular medical follow up and care.
✓. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
✓. Currently nonsmoking and no history of using nicotine/tobacco-containing products for ≥ 5 years prior to screening.
✓. Normal chest X-ray, per opinion of the Investigator.
✓. FEV1 ≥ 80% of predicted values.
✓. No history or current illicit, pharmaceutical drug or alcohol abuse within ≤ 5 years prior to screening.
Exclusion criteria
✕. Female subjects who are currently pregnant or lactating.
✕
What they're measuring
1
Clinical safety profile (adverse events) - Single Ascending Dose