ADO-5030 in Bronchoconstriction Challenge, Phase 1b

Starting soon · Phase 1

Conditions studied: Asthma (Diagnosis)

In brief

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.

Key facts

Study ID

NCT07281274

Run by

Adovate

People needed

36

Starts

2026-01-01

Expected to finish

2026-07-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours.
• Pregnancy or nursing a baby.
• A positive history for HIV, TB, HBV, or HCV.
• 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.
• Uncontrolled asthma at enrollment Visit 1 defined as ACT score <20.
• 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.
• Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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