Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Corbus Pharmaceuticals Inc.
With
Cystic Fibrosis Foundation
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.
2. Weight ≥ 40 kg.
3. FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.
You may not be if
1. Severe or unstable CF at screening or Visit 1.
2. Any of the following values for laboratory tests at screening:
1. A positive pregnancy test.
2. Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
3. Neutrophils \< 1.0 x 10\^9 /L.
4. Platelets \< 75 x 10\^9/L.
5. Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
6. Serum transaminases \> 2.5 x upper limit of normal.
3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
