Not Yet RecruitingPhase 1

ADO-5030 in Bronchoconstriction Challenge, Phase 1b

United States36 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Change from baseline in PC20 AMP.

Timeframe: As this is a single dose trial, the timeframe is the duration in which PC20 AMP is reached during the AMP Challenge with ADO-5030 on Day 1.

Trial details

NCT IDNCT07281274

SponsorAdovate

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Deborah Murphy, BSN

434-982-3510 ddm9q@uvahealth.org

View on ClinicalTrials.gov More Asthma (Diagnosis) trials