ADO-5030 for Asthma

Overseen By Deborah Murphy, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adovate

Must not be taking: Inhaled corticosteroids, Cromolyn, LABA, Leukotriene modifiers

Disqualifiers: Cardiovascular disease, Uncontrolled diabetes, Chronic renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ADO-5030, an experimental drug, to determine if it can reduce asthma symptoms in adults with mild to moderate asthma. It also evaluates the safety and comfort of taking ADO-5030. Individuals who have managed mild to moderate asthma for at least six months may be suitable for this trial. Participants will visit the clinic several times, take one oral dose of ADO-5030, and undergo breathing tests. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

You will need to stop using inhaled corticosteroids, cromolyn, long-acting beta-agonists, and leukotriene modifiers for 48 hours before participating in the trial.

Is there any evidence suggesting that ADO-5030 is likely to be safe for humans?

Research has shown that ADO-5030 underwent testing in earlier studies to ensure safety. In these studies, healthy volunteers took varying doses of ADO-5030 to observe their body's responses. So far, participants have tolerated the treatment well, with no major safety issues reported.

Preclinical tests also support its safety and suggest that ADO-5030 may target the airways specifically, potentially reducing side effects. As this trial is in its early phase, ensuring participant safety remains the top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard asthma treatments, such as inhaled corticosteroids and bronchodilators that primarily focus on reducing inflammation or relaxing airways, ADO-5030 is unique because it targets a different pathway involved in asthma attacks. Researchers are excited about ADO-5030 because it introduces a new mechanism of action that could offer relief for patients who do not respond well to existing therapies. This new approach has the potential to not only improve symptoms but also reduce the frequency of asthma exacerbations, offering a promising alternative for better asthma management.

What evidence suggests that ADO-5030 might be an effective treatment for asthma?

Research has shown that ADO-5030 is under study for its potential to reduce asthma symptoms. A previous study tested ADO-5030's ability to help adults with mild to moderate asthma breathe easier during attacks. Although detailed results are not yet available, the study aimed to assess the treatment's safety and effectiveness. Early interest in ADO-5030 highlights its promise in addressing asthma-related issues. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with mild to moderate asthma who can visit the clinic 3-4 times and undergo respiratory challenges are eligible for this trial. It's not specified who cannot join, but typically those with severe conditions or allergies related to the treatment may be excluded.

Inclusion Criteria

Willing to abstain from caffeine for 24 hours prior to each AMP challenge

Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2

My asthma is well controlled, with an ACT score of 20 or more.

Exclusion Criteria

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

I have smoked at least 10 pack-years but haven't smoked in the last year.

My asthma is not well-controlled, with an ACT score below 20.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive a single oral dose of 1500 mg ADO-5030 followed by an AMP challenge 90 minutes later

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events

9 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ADO-5030

Trial Overview

The trial is testing ADO-5030, a medication given orally to see if it reduces asthma symptoms during controlled respiratory challenges. The study will assess its effectiveness and safety in asthmatic adults.

How Is the Trial Designed?

Group I: ADO-5030 Experimental Treatment 1 Intervention

This is a single-arm study. All participants will receive ADO-5030.

Who Is Running the Clinical Trial?

Adovate

Lead Sponsor

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07281274

ADO-5030 in Bronchoconstriction Challenge, Phase 1b

The goal of this clinical trial is to learn if ADO-5030 reduces asthma symptoms during a respiratory challenge in adults with mild to moderate ...

2.

adial.com

adial.com/adial-pharmaceuticals-reports-first-quarter-2025-financial-results-and-provides-business-update/

Adial Pharmaceuticals Reports First Quarter 2025 ...

Adial Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update - Adial Pharmaceuticals Inc.

3.

synapse.patsnap.com

synapse.patsnap.com/organization/dbc91f926071360c4a6e4a6e7d0ce923

Adovate LLC - Drug pipelines, Patents, Clinical trials

Clinical Results associated with Adovate LLC. Login to view more data. 0 ... Start your data trial now! Synapse data is also accessible to external entities via ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40873794/

Monoclonal antibodies in severe asthma: outcomes from ...

Median ACT scores increased by six points, and FEV₁ improved by 7%. Annual exacerbation rates and healthcare utilization decreased significantly ...

5.

globenewswire.com

globenewswire.com/news-release/2025/05/15/3082141/26135/en/Adial-Pharmaceuticals-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Update.html

Adial Pharmaceuticals Reports First Quarter 2025 Financial

... Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate's lead compound for asthma, ADO-5030. This milestone ...

6.

adisinsight.springer.com

adisinsight.springer.com/trials/700382842

A phase 1 study of Single Ascending Dose (SAD) of ADO ...

To evaluate the safety, tolerability, and pharmacokinetics of ADO-5030 in healthy volunteers.

7.

biospace.com

biospace.com/press-releases/adial-pharmaceuticals-receives-milestone-payment-from-adovate-following-initiation-of-phase-1-study

Adial Pharmaceuticals Receives Milestone Payment from ...

The ongoing Phase 1 study is a Single Ascending Dose (SAD) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of ...

8.

nasdaq.com

nasdaq.com/articles/adial-pharmaceuticals-receives-development-milestone-payment-adovate-following-phase-1

Adial Pharmaceuticals Receives Development Milestone ...

The Phase 1 trial aims to assess the safety and pharmacokinetics of ADO-5030, which targets a significant unmet need in asthma treatment.

9.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT07281274

ADO-5030 in Asthma (Diagnosis) - Clinical Trials Registry

This study is a single-center, single-arm, Phase 1b clinical trial evaluating the efficacy, safety, and biological effects of ADO-5030, a ...