Testing AER-01 for COPD treatment
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of AER-01 (Solution for Inhalation, Delivered Via Nebulizer): As a First-In-Human Single Ascending Dose in Healthy Volunteers (Part A), and a 7-day Multiple Ascending Dose in Healthy Volunteers(Part B)
PHASE1 · Aer Therapeutics · NCT05862623
This study is testing a new inhaled treatment for COPD to see if it is safe and how well it works compared to a placebo.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aer Therapeutics (industry) |
| Locations | 2 sites (Adelaide and 1 other locations) |
| Trial ID | NCT05862623 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates AER-01, a solution for inhalation delivered via nebulizer, in a first-in-human, randomized, double-blind, placebo-controlled Phase 1 study. The trial consists of two parts: a single ascending dose (SAD) part involving healthy volunteers and a multiple ascending dose (MAD) part over seven days. The primary focus is to assess the safety, tolerability, and pharmacokinetics of AER-01. Participants will receive either the active drug or a placebo to determine the drug's effects.
Who should consider this trial
Good fit: Ideal candidates for this study include healthy volunteers aged 18 to 65 and patients with moderate airflow limitation due to COPD.
Not a fit: Patients with unstable medical conditions or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with COPD.
How similar studies have performed: Other studies have shown promise with similar inhalation therapies for COPD, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Health Volunteers: * Healthy volunteers: Male or female aged ≥18 to ≤65 years. * Current non-smoker or casual smoker Participants * Females must not be pregnant or lactating Exclusion Criteria: * History of unstable medical conditions or major surgical procedures over the 12 months prior to Screening. * History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the PI or designee might obfuscate the study data. * History of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before Screening. Part B Participants with COPD and Moderate Airflow Limitation * Has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.
Where this trial is running
Adelaide and 1 other locations
- CMAX — Adelaide, Australia (RECRUITING)
- Scientia Clinical Research — Sydney, Australia (RECRUITING)
Study contacts
- Principal investigator: Emir Redzepagic, MD — CMAX Clinical Research
- Study coordinator: Jordan Low
- Email: clinical@aertherapeutics.com
- Phone: 919-345-4256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD