RecruitingPhase 1NCT07554365

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

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


Sponsor

AirNexis Therapeutics, Inc.

Enrollment

24 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AN01 and a drug called Placebo for people with healthy participants study and healthy volunteer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAN01

Active study drug

DRUGPlacebo

Placebo


Locations(1)

Site 103

Adelaide, South Australia, Australia

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NCT07554365


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