ADO-5030 in Bronchoconstriction Challenge, Phase 1b

NCT07281274 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ADO-5030-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis)

Keywords

AMP Challenge; Bronchoconstriction Challenge; Respiratory Challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).

  Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.

• Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).

  Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.

• Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs).

  Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.

• Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs).

  Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.

• Frequency of Adverse Events (AEs).

  Enrollment to End of Study, assessed up to 9 days post-dose.

Study Arms (1)

ADO-5030

EXPERIMENTAL

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

Drug: ADO-5030

Interventions

ADO-5030 DRUG

Single oral dose of ADO-5030.

ADO-5030

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to abstain from caffeine for 24 hours prior to each AMP challenge.
• Willing and able to give informed consent.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Adovate: lead
• University of Virginia: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Deborah Murphy, BSN

CONTACT

434-982-3510; ddm9q@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)