Asthma (Diagnosis)Phase 1NCT07281274
ADO-5030 in Bronchoconstriction Challenge, Phase 1b
A Phase 1 study testing ADO-5030 in people with Asthma (Diagnosis), run by Adovate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- ADO-5030
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
Deborah Murphy, BSN, 434-982-3510, ddm9q@uvahealth.org
Larry Borish, MD
About this study
Official title: 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.
- Conditions
- Asthma (Diagnosis)
- Being tested
- ADO-5030
- Keywords
- AMP Challenge, Bronchoconstriction Challenge, Respiratory Challenge
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADO-5030Drug
Single oral dose of ADO-5030.
| Study group | Role | What they receive |
|---|---|---|
| ADO-5030 | Experimental | This is a single-arm study. All participants will receive ADO-5030. Receives: Drug: ADO-5030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PC20 AMP.
PC20 AMP is defined as the provocative concentration of AMP resulting in a 20% fall from baseline in FEV1. FEV1 is defined as the amount of air you can forcefully exhale in one second.
Measured: 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.
Secondary outcomes (6)
Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Frequency of TEAEs will be reported.
Measured: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Severity of TEAEs will be reported.
Measured: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs).
TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Frequency of TRAEs will be reported.
Measured: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs).
TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Severity of TRAEs will be reported.
Measured: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Frequency of Adverse Events (AEs).
The frequency of all AEs reported by subjects will be reported.
Measured: Enrollment to End of Study, assessed up to 9 days post-dose.
Severity of Adverse Events (AEs).
The severity of all AEs reported by the subject will be reported.
Measured: Enrollment to End of Study, assessed up to 9 days post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adovate
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281274
- Sponsor's protocol ID
- ADO-5030-102
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge
- ClinicalTrials.gov ID
- NCT07281274
- Acronym / sponsor ID
- ADO-5030-102
- Conditions
- Asthma (Diagnosis)
- Keywords
- AMP Challenge, Bronchoconstriction Challenge, Respiratory Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AdovateIndustry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADO-5030 | Experimental | Drug: ADO-5030This is a single-arm study. All participants will receive ADO-5030. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADO-5030Single oral dose of ADO-5030. | Drug | ADO-5030 |
Primary outcome
Change from baseline in PC20 AMP.
Time frame: 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.
PC20 AMP is defined as the provocative concentration of AMP resulting in a 20% fall from baseline in FEV1. FEV1 is defined as the amount of air you can forcefully exhale in one second.
6 secondary outcomes
Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs).
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs).
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Frequency of Adverse Events (AEs).
Time frame: Enrollment to End of Study, assessed up to 9 days post-dose.
Severity of Adverse Events (AEs).
Time frame: Enrollment to End of Study, assessed up to 9 days post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADO-5030 in people with Asthma (Diagnosis), run by Adovate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Murphy, BSN (434-982-3510, ddm9q@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in PC20 AMP. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.