Safety and dosing of inhaled AN01 in healthy adults

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

This trial will test inhaled AN01 in healthy adults to see if it is safe, well tolerated, and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: AirNexis Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT07554365 on ClinicalTrials.gov

What this trial studies

AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 delivered as an inhalation powder and being developed as a potential COPD therapy. This Phase 1 study uses three multiple-ascending-dose cohorts in healthy adults who are randomized to receive either placebo or ascending doses of AN01 in a double-blinded manner. The trial will collect safety, tolerability, and pharmacokinetic data across repeated doses. Results will inform dosing and safety for future patient studies.

Who should consider this trial

Good fit: Healthy adults aged 18–60 with BMI 18–32 kg/m2, non-smokers or former light smokers who pass medical screening and meet the study's contraception or sterility requirements are eligible.

Not a fit: People with COPD or other active medical conditions, current smokers, pregnant or breastfeeding women, and those outside the age or BMI ranges are unlikely to gain therapeutic benefit from participating.

Why it matters

Potential benefit: If successful, AN01 could become an additional inhaled treatment option for COPD, used alone or together with existing inhaled therapies to improve symptoms for some patients.

How similar studies have performed: Oral PDE4 inhibitors have shown benefit in COPD, but inhaled dual PDE3/4 inhibition like AN01 is a relatively novel approach with limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. Healthy adults ≥18 and ≤60 years (inclusive).
2. Body Mass Index (BMI) ≥18 and ≤32 kg/m2 (inclusive).
3. Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, spirometry, and electrocardiogram (ECG).
4. Non-smokers or former smokers who have quit for ≥2 years with a prior smoking history of \<5 pack-years (pack-years defined as = cigarettes per day × years smoked; 1 pack = 20 cigarettes).
5. Female participants must be non-pregnant and non-lactating, and, surgically sterile, use highly effective contraceptive methods from Screening until at least 30 days after the last dose of study drug, or post-menopausal for ≥12 months.
6. Male participants must be surgically sterile, abstinent, or their partner must be surgically sterile, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the male participant and his partner must use an acceptable, highly effective contraceptive method from Screening until at least 90 days after the last dose of study drug.

Exclusion Criteria:

1. History of clinically significant (as per Investigator's judgment) upper respiratory disease or history of any significant pulmonary disease including, but not limited to, asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and history of previous tuberculosis exposure with positive interferon gold test (without actual infection).
2. Participants with any history of, or active, clinically significant disease (e.g., cardiovascular disease, chronic liver disease, psychiatric medical history, renal disease) that could interfere with the interpretation of the study results or compromise the health of the participant based on the judgment of the Investigator.
3. Administration of vaccines/immunizations and/or boosters within 8 days prior to first dosing or if planned during the study.
4. Any history of active infection at the time of Screening and/or within 28 days prior to first dosing.
5. Any prior participation in a study with an investigational drug or device involving a biological targeted therapy, where final administration of the investigational drug or utilization of the device occurred within 24 weeks prior to first dosing.
6. History of migraine headaches requiring prescription medication or occurring more than 2-4 times per month within the past 6 months.
7. Use of non-tobacco vaping within 12 months prior to Screening.
8. Use of any tobacco and/or inhaled marijuana product within 2 years prior to Screening.

Where this trial is running

Adelaide, South Australia

• Site 103 — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Clinical Trial Manager

Conditions Healthy Volunteer; Healthy Participants Study