A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in PC20 AMP.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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.
排除标准
- •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 <
- •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
- •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).
研究组 & 干预措施
ADO-5030
This is a single-arm study. All participants will receive ADO-5030.
干预措施: ADO-5030 (Drug)
结局指标
主要结局
Change from baseline in PC20 AMP.
时间窗: 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.
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.
次要结局
- 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.)
- Severity of Adverse Events (AEs).(Enrollment 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.)