A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge
Adovate
Summary
This is a Phase 1 study to learn about the safety and pharmacokinetics of the study drug in patients with asthma and whether the study drug has effect during a respiratory challenge.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females ages 18-65 years, inclusive 2. History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening. 3. Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1. 4. Reactivity to AMP, as determined in Protocol 19512 (Screening Protocol of Asthmatic, Allergic Rhinitic, or Control Participants for Experimental Challenges). Reactivity is defined as having a PC20 AMP at or before 80mg/mL. 5. Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 day…
Interventions
- DrugADO-5030
Single oral dose of ADO-5030.
Location
- University of VirginiaCharlottesville, Virginia