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

Summary

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.

Timeline

Start

2020-02-11

Primary completion

2020-08-31

Completion

2020-08-31

Publications

• Caponetti G, Sala F, Cervetti A, Colombo D, Tiberio E, Singh D. Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Inhaled Voriconazole in Healthy Volunteers and Subjects With Stable Asthma. Pharmacol Res Perspect. 2025 Feb;13(1):e70064. doi: 10.1002/prp2.70064.

Drugs

Indications