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Metal Chelator

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days following dose administration

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days following dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days following dose administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical safety profile (adverse events) - Multiple Ascending Dose
Clinical safety profile (adverse events) - Single Ascending Dose
Secondary study objectives
Pharmacokinetics (PK) Profile - MAD AUC0-inf
Pharmacokinetics (PK) Profile - MAD AUC0-last
Pharmacokinetics (PK) Profile - MAD Clp
+11 more

Trial 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.
2 Previous Clinical Trials
36 Total Patients Enrolled
~15 spots leftby Dec 2025
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