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Phase 1/1b study of inhaled formulation in healthy volunteers & asthmatics
PUR1900 is an iSPERSE™ formulation incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. Patients with severe asthma and CF are afflicted with ABPA, a complex hypersensitivity reaction that occurs in response to colonization of the airways with Aspergillus fumigatus.
This Phase I study was designed to evaluate the safety, tolerability and PK of single and multiple ascending doses of PUR1900 capsules administered as dry powder for inhalation in Part 1 (single ascending dose; SAD) and Part 2 (multiple ascending dose; MAD) respectively, in healthy volunteers.