Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis

Exclusion Criteria

• •Severe or unstable CF, such as:
• •1. Intravenous antibiotic treatment within 14 days before Visit 1
• •2. Treatment with any corticosteroids \> 10 mg per day or \> 20 mg every other day oral prednisone or equivalent within 14 days before Visit 1
• •Any one of the following values for laboratory tests at Screening:
• •1. A positive pregnancy test (or at Visit 1);
• •2. Hemoglobin \< 10 g/dL
• •3. Neutrophils \< 1.0 x 10\~9/L
• •4. Platelets \< 75 x 10\~9/L
• •5. Creatinine clearance \< 50 ml/min according to modified Cockcroft-Gault equation
• •6. Serum transaminases \> 2.5 x upper normal limit
• •7. Total bilirubin ≥ 1.5 x upper limit of normal
• •Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.