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NOT YET RECRUITING
NCT07554365
PHASE1

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

Sponsor: AirNexis Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-05

Completion Date

2026-06

Last Updated

2026-04-28

Healthy Volunteers

Yes

Interventions

DRUG

AN01

Active study drug

DRUG

Placebo

Placebo

Locations (1)

Site 103

Adelaide, South Australia, Australia