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Not yet recruiting NCT07281274

ADO-5030 in Bronchoconstriction Challenge, Phase 1b

Phase I Interventional Asthma (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADO-5030.
Who it may be relevant to
Registry conditions: Asthma (Diagnosis). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge

Overview

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.

Interventions

  • Drug ADO-5030
    Single oral dose of ADO-5030.

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT07281274 · ADO-5030-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗