ADO-5030 in Bronchoconstriction Challenge, Phase 1b

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma (Diagnosis)
• Intervention / Treatment: Drug: ADO-5030

Detailed Description

This study is a single-center, single-arm, Phase 1b clinical trial evaluating the efficacy, safety, and biological effects of ADO-5030, a selective adenosine A2B receptor antagonist, in adults with well-controlled mild to moderate asthma undergoing a bronchoconstriction challenge. The clinical investigation addresses whether a single oral dose of ADO-5030 modulates airway reactivity as measured by the Adenosine-5-monophosphate (AMP) challenge.

The protocol consists of a screening phase (including two AMP challenges within 28 days), a treatment phase (single open-label dose of 1500 mg ADO-5030 oral suspension followed by AMP challenge 90 minutes later), and a safety follow-up. Laboratory, spirometry, physical examination, vital signs, and asthma control tests (ACT) are repeated at multiple time points.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Deborah Murphy, BSN; Phone Number: 434-982-3510; Email: ddm9q@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia
      • Principal Investigator: Larry Borish, MD
      • Contact: Deborah Murphy, BSN; Phone Number: 434-982-3510; Email: ddm9q@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females ages 18-65 years, inclusive
2. History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening.
3. Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1.
4. 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.
5. Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 days of each other.
6. Pre-bronchodilator FEV1 ≥ 60% of predicted at screening.
7. Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2.
8. Negative pregnancy test for females who have not had a hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
9. Willing to abstain from caffeine for 24 hours prior to each AMP challenge.
10. Willing and able to give informed consent.

Exclusion Criteria:

1. 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.
2. Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours.
3. Pregnancy or nursing a baby.
4. A positive history for HIV, TB, HBV, or HCV.
5. 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.
6. Uncontrolled asthma at enrollment Visit 1 defined as ACT score <20.
7. 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.
8. Known allergy/sensitivity to theophylline.
9. 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.
10. 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.
11. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADO-5030; This is a single-arm study. All participants will receive ADO-5030.	Drug: ADO-5030; Single oral dose of ADO-5030.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Enrollment to End of Study, assessed up to 9 days post-dose.

Collaborators and Investigators

• Sponsor: Adovate
• Collaborators: University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: AMP Challenge; Bronchoconstriction Challenge; Respiratory Challenge
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Asthma; Disease
• Other Study ID Numbers: ADO-5030-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No