Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Humanigen, Inc.
Age
12–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit
Confirmed diagnosis of CF
At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening)
FEV1 % levels within acceptable ranges (per the study protocol)
Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit
You may not be if
Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit
History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit
History of organ transplantation
Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited
History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction
Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer
