Krystal Biotech, Inc. announced that it has been granted approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to conduct a Phase 1 clinical study of inhaled KB407 in patients with cystic fibrosis (CF). The Company previously received license to evaluate KB407 from Australia's Office of the Gene Technology Regulator (OGTR). KB407 is an engineered viral vector designed to deliver full-length human cystic fibrosis transmembrane conductance regulator (CFTR) to the airways of people with cystic fibrosis via nebulization. Study enrollment is expected to begin shortly following approval by the trial site’s institutional governance and biosafety committee. The primary endpoint of the trial will be the safety and tolerability of nebulized KB407. Changes in lung function from baseline will be assessed by forced expiratory volume in one second (FEV1) and measurement of lung clearance index (LCI) from multiple-breath washout (MBW) testing. Subjects may receive an optional intradermal dose of neat drug product, enabling a minimally invasive biopsy and assessment of CFTR expression via q-PCR.