ACTRN12619000227190已完成1 期
A Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled gdc-4379 conducted in three parts: a single ascending dose study in healthy volunteers, a multiple ascending dose study in healthy volunteers, and a proof-of-activity study in patients with mild asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Genentech
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria for Healthy Volunteers
- •Signed Informed Consent Form
- •Age 18-65 years
- •Body mass index of 18-37 kg/m2
- •Weight of 50-120 kg
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs.
- •First forced expiratory volume (FEV1) >70 % predicted
- •Forced vital capacity (FVC) >2.0 L
- •Ability to demonstrate sufficient inspiratory effort using the inhaler training
- •Ability to comply with the study protocol, including all study procedures
- •Agreement to remain abstinent or use contraceptive methods
- •FeNO >25 ppb at screening for one specific cohort
- •Key Inclusion Criteria for Patients with Mild Asthma
- •Signed Informed Consent Form
- •Age 18-65 years
- •Body mass index of 18-37 kg/m2
- •Weight of 50-120 kg
- •Documented physician-diagnosed mild asthma for at least 6 months prior to screening, defined as: Asthma that is controlled with as-needed reliever medication with or without a leukotriene receptor antagonist
- •No use of inhaled corticosteroids within 60 days prior to initiation of study drug
- •FeNO >40 ppb at screening and at pre-randomization visit
- •No clinically significant ECG abnormalities
- •Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor.
- •FEV1 >70 % predicted
- •FVC >2.0 L
- •Ability to demonstrate sufficient inspiratory effort using the inhaler training device
- •Ability to comply with the study protocol, including all study procedures
- •Agreement to remain abstinent or use contraceptive methods
排除标准
- •Key Exclusion Criteria for Healthy Volunteers
- •Subjects who meet any of the following criteria will be excluded from Parts A and B:
- •History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders, in the investigator’s judgment
- •History of malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
- •History of nasal polyposis or nasal polyps identified during screening physical examination
- •History of anaphylaxis, hypersensitivity, or significant drug allergies
- •History of severe hypersensitivity to milk proteins
- •History or presence of an abnormal ECG that is clinically significant
- •Any medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the subject’s safe participation in and completion of the study
- •Illicit drug or alcohol abuse within 12 months prior to initiation of study drug
- •Positive alcohol screen at screening or pre-randomization
- •Recent history of smoking within the 30 days prior to initiation of study drug
- •Smokers not able to pass the tobacco-related screening and who cannot refrain from smoking during the study
- •Positive urine test for selected drugs of abuse at screening
- •Pregnant or breastfeeding, or intending to become pregnant during the study
- •Women of childbearing potential must have a negative pregnancy test result at screening or pre-randomization.
- •Use of any prescription medications and products within 7 days prior to initiation of study drug and throughout the study
- •Use of a investigational drug or recent participation in an investigational study
- •Positive for hepatitis panel at screening
- •Exclusion Criteria for Patients with Mild Asthma
- •Subjects who meet any of the following criteria will be excluded from Part C:
- •Any of the exclusion criteria for healthy volunteers above
- •Use of ICS therapy within 60 days prior to initiation of study drug
- •Lack of asthma control defined as respiratory symptoms requiring use of a reliever inhaler (e.g., 2 puffs of SABA) more than twice a day on a regular basis within 4 weeks prior to initiation of study drug (not including reliever medication used to prevent symptoms)
- •Recent asthma exacerbation requiring oral corticosteroid use or urgent medical care for asthma within 12 weeks prior to initiation of study drug
- •Any asthma-related history, symptoms, or findings that precludes the subject’s safe participation in and completion of the study in the investigator’s judgment
- •Positive nasopharyngeal PCR test for SARS-COV-2 within 10 days prior to initiation of study drug
研究者
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