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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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