KB407-02 A Phase 1 Study of Inhaled KB407, a Replication-Defective, Non-Integrating Vector Expressing Human Cystic Fibrosis Transmembrane Conductance Regulator, for the Treatment of Cystic Fibrosis
This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
• The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions
• Subjects aged 18 years or older at the time of Informed Consent
• A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:
‣ A historical sweat chloride value \>60 mmol/L
⁃ Two copies of a disease causing mutation in the CFTR gene
• Clinically stable in the opinion of the Investigator
• Percent predicted FEV1 ≥40% and ≤100% of the predicted normal for age, gender, and height at Screening
• Resting oxygen saturation ≥92% on room air at Screening