A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients

Inclusion Criteria

• Subjects with hematologic malignancies or recipients of a first allogeneic or autologous hematopoietic stem cell transplantation and presently clinically stable
• Pulse oximetry of hemoglobin saturation ≥92% on room air
• Adult (≥18 years)
• Spirometry (FEV1 and forced vital capacity [FVC]) ≥80% of predicted value
• If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control
• If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• If male, must be surgically sterile or willing to practice two effective methods of birth control
• Ability to understand and give informed consent

Exclusion Criteria

• Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)
• Known history of chronic pulmonary disease
• Subjects who are being treated for fungal, viral, or bacterial pneumonia
• Exposure to any investigational agent (defined as any agent not approved by the Food and Drug Administration [FDA]) within 30 days prior to the Screening Visit
• Patients with a relapsed and/or refractory underlying hematologic malignancy
• HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation
• HSCT recipients with active and/or chronic graft versus host disease
• Patients on systemic corticosteroids (oral or intravenous)
• Absolute neutrophil count (ANC) < 1,000 cells/mL
• Clinically significant bacteremia or fungemia
• Current smokers or subjects with any history of smoking