Single and Multiple Ascending Dose Study of AER-01 (NCT05862623) | Clinical Trial Compass
UnknownPhase 1
Single and Multiple Ascending Dose Study of AER-01
Australia72 participantsStarted 2023-05-26
Plain-language summary
This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)