Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated May 28, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4). As a potential new therapy for COPD, AN01 is expected to serve either as a monotherapy for COPD or as adjunctive therapy to current inhaled standard treatments, potentially generating synergistic complementary effects in patients requiring additional therapeutic options. The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of AN01 in healthy participants.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-06
Trial Details
NCT Number NCT07554365
Lead Sponsor AirNexis Therapeutics, Inc.
Conditions Healthy Volunteer, Healthy Participants Study
Enrollment 24 participants
Start Date 2026-05-13
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-28