ADO-5030 in Bronchoconstriction Challenge, Phase 1b

NCT ID: NCT07281274

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-07-01

Brief Summary

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 asthma. It will also learn about the safety and tolerability of ADO-5030 in asthmatics. The main questions it aims to answer are:

• Does ADO-5030 reduce asthma symptoms during the respiratory challenge?
• Is ADO-5030 safe and tolerable for adults with mild to moderate asthma?

Participants will:

• Visit the clinic 3 or 4 times.
• Undergo 2 or 3 respiratory challenges.
• Be given a single oral dose of 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.

Conditions

Asthma (Diagnosis)

Keywords

AMP Challenge; Bronchoconstriction Challenge; Respiratory Challenge

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADO-5030

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

Group Type: EXPERIMENTAL

ADO-5030

Intervention Type: DRUG

Single oral dose of ADO-5030.

Interventions

ADO-5030

Single oral dose of ADO-5030.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Adovate

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Central Contacts

Deborah Murphy, BSN

Role: CONTACT

Phone: 434-982-3510

Email: ddm9q@uvahealth.org

Facility Contacts

Deborah Murphy, BSN

Role: primary

Other Identifiers

ADO-5030-102

Identifier Type: -

Identifier Source: org_study_id