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Metal Chelator
Inhaled AR-501 for Cystic Fibrosis
Phase 1 & 2
Recruiting
Research Sponsored by Aridis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Written informed consent given by the subject.
At least ≥ 18 years old and < 50 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days following dose administration
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of inhaled AR-501 to treat P. aeruginosa-infected cystic fibrosis in healthy adults.
Eligible Conditions
- Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days following dose administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days following dose administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical safety profile (adverse events) - Multiple Ascending Dose
Clinical safety profile (adverse events) - Single Ascending Dose
Secondary outcome measures
Pharmacokinetics (PK) Profile - MAD AUC0-inf
Pharmacokinetics (PK) Profile - MAD AUC0-last
Pharmacokinetics (PK) Profile - MAD Clp
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AR-501 inhaledExperimental Treatment1 Intervention
Four doses (low, medium, high, top) of inhaled AR-501 will be used.
Group II: inhaled AR-501 PlaceboPlacebo Group1 Intervention
Four doses (low, medium, high, top) of inhaled placebo will be used
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Aridis Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
960 Total Patients Enrolled
Hasan S Jafri, MD, FAAPStudy DirectorAridis Pharmaceuticals, Inc.
1 Previous Clinical Trials
174 Total Patients Enrolled
Alan H Cohen, MDStudy DirectorAridis Pharmaceuticals, Inc.
Frequently Asked Questions
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