A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)

Inclusion Criteria: * Greater than or equal to 18 years of age at Screening * Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1 * Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: 1. sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT) 2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene 3. Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV) * FEV1 ≥ 25 % of predicted value at Screening * Able to expectorate sputum * Serum liver function tests ≤ 2.5 x upper limit of normal at Screening * Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening * Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening * Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC) ≥ 4,500/mm3 at Screening * Ionized calcium ≥ lower limit of normal at Screening * Written informed consent obtained from subject or subject's legal representative * Able to communicate with the Investigator and comply with the requirements of the protocol * If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug * If female and of childbearing potential, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator * If male and able to father a child, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator * Clinically stable with no significant changes in health status within 14 days prior to Day 1 Exclusion criteria: * Use of inhaled antibiotics within seven days prior to Day 1 * Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28 * Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1 * Use of bisphosphonates within seven days prior to Day 1 * History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening) * Lactating female * Known sensitivity to gallium