Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
The primary safety objectives were: * Part 1: To determine the safety and tolerability of single doses of ZP-059 in healthy subjects * Part 2: To determine the safety and tolerability of multiple doses of ZP-059 in subjects with mild stable asthma * Part 3: To determine the safety and tolerability of single doses of ZP-059 in subjects with mild to moderate stable asthma. The primary PK objectives were: * Part 1: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 in healthy subjects * Part 2: To characterize systemic PK of voriconazole and N-oxide voriconazole after multiple doses of ZP-059 in subjects with mild stable asthma * Part 3: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 and single doses of oral voriconazole in subjects with mild to moderate stable asthma.
Epistemonikos ID: 0bdd55680ad3f9e639c3f96b9c1344da08dc4690
First added on: May 07, 2024