Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Adults Aged 18 to 60

What this Trial Is About

Researchers are evaluating AN01, a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 PDE34, as a potential new therapy for chronic obstructive pulmonary disease COPD. This study focuses on assessing the safety, tolerability, and how the body processes multiple doses of AN01 in healthy adult participants. The trial is designed as a phase 1 study and sponsored by AirNexis Therapeutics, Inc. The study includes three multiple ascending dose MAD groups where participants are randomly assigned to receive either placebo or increasing doses of AN01 in a double-blinded manner. An additional dose group may be added by the sponsor if needed. Treatments are given as inhalation powder, with the dosing period lasting up to 14 days. Participants will undergo various health assessments including physical exams, vital signs, laboratory tests, lung function tests spirometry, respiratory assessments, and heart monitoring via 12-lead electrocardiogram ECG from day 1 through day 14. The study also collects blood samples to analyze how AN01 is absorbed, distributed, metabolized, and eliminated. Researchers will monitor for any side effects or abnormal results during and shortly after dosing to evaluate safety and tolerability.

A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants