RightFit
Not yet recruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests the safety of ADO-5030 and how the body handles it. It also checks whether the drug has an effect during a breathing challenge in adults with well-controlled mild or moderate asthma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Have had mild or moderate ongoing asthma for at least 6 months, with a score of 20 or higher on the asthma control test.
  • Have airways that narrow enough during an AMP breathing challenge at a dose of 80 mg/mL or less, as checked in the screening study.
  • Have similar results on two AMP breathing challenges done within 28 days of each other.
  • Have a breathing test result called FEV1 of at least 60% of the expected value before taking medicine to open the airways.
  • Have safety lab results that are normal or do not raise medical concerns.
  • Have a negative pregnancy test if required. The listed exceptions are removal of the uterus and ovaries, or no periods for at least 12 months.
  • Be willing to avoid caffeine for 24 hours before each breathing challenge and able to give informed consent.

Who can't join

  • Have a long-term illness that the study doctor thinks makes joining unsafe, or a history of HIV, tuberculosis, hepatitis B, or hepatitis C.
  • Cannot stop certain asthma medicines for 48 hours: inhaled steroids, cromolyn, long-acting airway-opening medicines, or leukotriene blockers.
  • Are pregnant or breastfeeding, or are sexually active and unwilling to use reliable birth control.
  • Have uncontrolled asthma, with an asthma control test score below 20; or have had an asthma flare needing oral steroids within 12 months, an overnight hospital stay, or an urgent care visit with extra asthma treatment.
  • Currently smoke, used inhaled tobacco in the past 12 months, or have smoked at least 10 pack-years—for example, one pack a day for 10 years.
  • Have an allergy or sensitivity to theophylline.
  • Had an infection needing antibiotics or a fever with no known cause within 4 weeks of screening. People who get a breathing infection during the study may enroll again.
  • Have a mental illness or history of drug or alcohol abuse that the study doctor thinks would make it hard to follow study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

VA