Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)


Options:
A: Inclusion Criteria:

* Diagnosis of CF as evidenced by a sweat chloride test \> 60mEq/L or by the presence of two known CF mutations
* Male or female, ages between 10-40 years old
* \> 30 kg body weight
* FEV1 \> 35% predicted for age and height
* Clinically stable with no recent hospitalization within the past 2 weeks

Exclusion Criteria:

* Significant liver disease as defined by clinical findings of portal hypertension or cirrhosis or AST, ALT, or GGT \>2x upper limits of normal within the previous 6 months
* Poor compliance with medical regimen as assessed by CF clinic care providers
* Oral supplementation with AquADEKs or another source of beta-carotene or CoQ10 in the 2 months prior to the study
* Pregnant or lactating
* Participation in another interventional clinical trial within the previous 2 weeks
* Difficulty swallowing softgels
B: Inclusion Criteria:

1. Cystic fibrosis
2. Age \> 18 years
3. Stable maintenance medical regimen during the previous 6 weeks.
4. Negative pregnancy test (women of childbearing potential) at both screening and baseline visits.
5. Women of childbearing potential must be using medically acceptable contraception.
6. At least two respiratory exacerbations per year requiring oral and/or intravenous antibiotics for each of the two years prior to study entry, but no more than 4 exacerbations requiring intravenous antibiotics during either of those years.

Exclusion Criteria:

1. Previous anti-reflux or peptic ulcer surgery,
2. Use of proton pump inhibitor (PPI) within the past two weeks
3. Pulmonary exacerbation requiring antibiotics within the previous 2 weeks
4. Parenteral hyperalimentation
5. Cigarette smoking
6. Treatment with azoles, iron, anti-coagulants, digitalis
7. Use of any investigative drugs within the previous month.
8. Use of over the counter acid suppressor agents (not including acid neutralizers)
C: Inclusion Criteria:

* Male or female ≥10 years of age
* Documentation of a Cystic Fibrosis (CF) diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:

  * Sweat chloride equal to or greater than 60 milliequivalent (mEq/L) by quantitative pilocarpine iontophoresis test (QPIT)
  * 2 well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
* Pancreatic insufficiency documented by having a spot fecal elastase-1 (FE-1) ≤ 100μg/g in a stool sample done either historically or at the screening visit
* Clinically stable with no significant changes in health status within 2 weeks prior to randomization
* Forced expiratory volume over one second (FEV1) ≥ 40 and ≤ 100% of predicted for age based on the Wang (males \< 18 years,females \< 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations at the screening visit
* Weight ≥ 30 kg at the screening visit
* Able to perform repeatable, consistent efforts in pulmonary function testing
* Able to tolerate sputum induction with 3% hypertonic saline and to expectorate with induction
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
* Ability to swallow softgel capsules

Exclusion Criteria:

* Subjects being treated with ivacaftor (Kalydeco™)
* Liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) \> 3 times the upper limits of normal at the screening visit
* Use of antibiotics (oral, iv, and/or inhaled) for acute respiratory symptoms within 2 weeks prior to randomization
* Active treatment for allergic bronchopulmonary aspergillosis (ABPA)
* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day
* Active treatment for nontuberculous mycobacterial (NTM) infection
* Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline,azithromycin,Tobramycin Inhalation solution (TOBI®), Cayston® within 8 weeks prior to randomization
* Unwilling to discontinue current oral vitamin and antioxidant supplementation (e.g.,AquADEKs®, another source of β-carotene, vitamin A, vitamin E or tocopherols,vitamins D or K, n-acetylcysteine, glutathione, CoQ10, other over-the-counter antioxidant) for the duration of the study
* Use of vitamins (other than control vitamin) or antioxidants within 4 weeks prior to randomization
* Daily use of \> 2 cans of Boost or Pulmocare dietary supplement formulas
* Known hypersensitivity to oral AquADEKs®
* For women of child bearing potential:

  1. positive pregnancy test at Visit 1 or at Visit 2, or
  2. lactating or
  3. unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
* Subject unlikely to complete the study as determined by the Investigator
* Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject
* Use of investigational therapies within 4 weeks prior to randomization
* Current tobacco smoker
* Current use of anticoagulant medications
* Severe malnutrition based either on having a BMI less than the 5th percentile for subjects \< 18 years of age or a body mass index (BMI) less than 18 kg/m2 for subjects \> 18 years of age.
* Subjects with poorly controlled CF-related diabetes on active insulin therapy, defined as having a Glycosylated Hemoglobin (HgbA1c) ≥ 7.5% at the most recent historic evaluation of HgbA1c
D: Inclusion Criteria:

* Written informed consent
* Confirmed diagnosis of CF based on the following criteria:

Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype

* Age \>/= 18 years of age with the potential for age 12 \>/=
* Screening Pa sputum culture
* FEV1% predicted \>/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)

Exclusion Criteria:

* Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
* Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
* History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
* Current cigarette smoker, history of drug addiction or alcohol abuse
* Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
* Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study

Answer: D