Tests ADO-5030 in adults with asthma during a breathing challenge
Tests ADO-5030, a new drug, in adults with asthma to check safety and effects.
Plain-language title generated from the registry record
Registry title: ADO-5030 in Bronchoconstriction Challenge, Phase 1b
Key facts
- Where
- Charlottesville, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07281274, who can take part
Where in United States
- University of VirginiaCharlottesville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Adovate
- Trial code
- NCT07281274
- Record updated
- 22 January 2026
- Original description
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.Read full original descriptionShow less
A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge
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.
Inclusion: Males and females ages 18-65 years, inclusive; History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening; Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1; 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; Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 days of each other; Pre-bronchodilator FEV1 ≥ 60% of predicted at screening; Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2; Negative pregnancy test for females who have not had a hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more; Willing to abstain from caffeine for 24 hours prior to each AMP challenge; Willing and able to give informed consent.
Exclusion: Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours; Any asthma exacerbation requiring oral corticosteroids within 12 months of screening or that resulted in overnight hospitalization or an urgent care visit requiring additional treatment for asthma; Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, uncontrolled diabetes, chronic renal disease, uncontrolled chronic thyroid disease, history of chronic infections or immunodeficiency; A positive history for HIV, TB, HBV, or HCV; Current smokers or a smoking history of ≥ 10 pack years. A subject may not have used any inhaled tobacco products in the 12-month period preceding Visit 1; Known allergy/sensitivity to theophylline; Any acute infection requiring antibiotics within 4 weeks or fever of unknown origin within 4 weeks of screening. Subjects having an intercurrent respiratory infection during the study will be permitted to reenroll; Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements; Pregnancy or nursing a baby; Uncontrolled asthma at enrollment Visit 1 defined as ACT score <20; Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).