Age

18–75

Sex

ALL

Healthy volunteers

Not accepted

Able to read, understand, and sign an informed consent form before any study procedures
Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
Demonstrated bronchodilator reversibility
ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults