Actively Recruiting
A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants
Led by AirNexis Therapeutics, Inc. · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 60 years (inclusive)
- Body Mass Index (BMI) between 18 and 32 kg/m2 (inclusive)
- Healthy as confirmed by medical history, physical exam, laboratory tests, spirometry, and ECG
- Non-smokers or former smokers who quit at least 2 years ago with less than 5 pack-years smoking history
- Female participants must be non-pregnant, non-lactating, surgically sterile, or use effective contraception from screening until 30 days after last dose, or be post-menopausal for at least 12 months
- Male participants must be surgically sterile, abstinent, or have partners who are surgically sterile, or use effective contraception from screening until 90 days after last dose if with a woman of childbearing potential
You will not qualify if you...
- History of significant upper respiratory disease or major lung diseases such as asthma, COPD, pulmonary fibrosis, or prior tuberculosis exposure with positive interferon gold test
- History of or active significant diseases like cardiovascular, liver, psychiatric, or renal conditions that could affect study results or participant health
- Vaccination or immunization within 8 days before first dose or planned during the study
- Active infection at screening or within 28 days before first dose
- Participation in investigational drug/device study with biological targeted therapy within 24 weeks before first dose
- History of migraine headaches requiring prescription or occurring more than 2-4 times monthly in past 6 months
- Use of non-tobacco vaping products within 12 months before screening
- Use of tobacco or inhaled marijuana products within 2 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Site 103
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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