Actively Recruiting
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
Led by AirNexis Therapeutics, Inc. · Updated on 2026-05-28
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AN01, a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4), 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.
CONDITIONS
Brief 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 based on medical history, physical exam, lab 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, use highly effective contraception during study and 30 days after last dose, or be post-menopausal for at least 12 months
- Male participants must be surgically sterile, abstinent, have a surgically sterile partner, or use highly effective contraception during study and 90 days after last dose
You will not qualify if you...
- History of significant upper respiratory or pulmonary diseases such as asthma, COPD, pulmonary fibrosis, or tuberculosis exposure with positive interferon gold test
- History or presence of significant diseases (cardiovascular, liver, psychiatric, renal) that could affect study results or participant health
- Receipt of vaccines or immunizations within 8 days before first dose or planned during study
- Active infection at screening or within 28 days before first dose
- Participation in a prior investigational drug or device study involving biological targeted therapy within 24 weeks prior to first dose
- History of migraine headaches requiring prescription medication or occurring more than 2-4 times per month in past 6 months
- Use of non-tobacco vaping 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive multiple ascending doses of AN01 inhalation powder or placebo in a randomized, double-blind manner.
Daily visits for up to 14 days
Duration - Up to 9 days after treatment
Participants are monitored for safety, tolerability, and pharmacokinetics after the last dose of study drug.
Visits on specified days up to Day 9 post-treatment
Trial Site Locations
Total: 1 location
1
Site 103
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
C
Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here