A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Arm, 4-Sequence, Crossover Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ang-3070 in Subjects With Idiopathic Pulmonary Fibrosis Who Are Treatment-Naïve or Who Have Failed or Refused Standard of Care Treatment
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 主要终点
- Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
研究概览
简要总结
The purpose of this study is to assess safety and tolerability of once daily (QD) and twice daily (BID) dosing of ANG-3070 in subjects with idiopathic pulmonary fibrosis (IPF) who are treatment-naïve, refused therapy, or discontinued for any reason current standard of care with nintedanib or pirfenidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be willing and of sufficient mental capacity to give written informed consent and comprehend the importance of adhering to study treatment and requirements.
- •Male or female subjects aged 40 years and older at the time of informed consent.
- •Substantiated diagnosis of IPF based on clinical, radiological, and/or pathologic data to the exclusion of alternate diagnoses that would contribute to extant interstitial lung disease (ILD) based on the opinion of the subject's physician using current diagnostic criteria.
- •Is naïve to therapy with nintedanib or pirfenidone OR
- •Refuses therapy with nintedanib or pirfenidone OR
- •Had nintedanib or pirfenidone discontinued due to any reason, 4-week washout required
排除标准
- •Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
- •Current tobacco use (quit at least 1 month prior to study for inclusion).
- •Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals.
- •Diagnosis of connective tissue disease.
- •Known cause of ILD diagnosed.
- •Active malignancy aside from local carcinoma.
- •AST or ALT or total bilirubin > 2x upper limit of normal (ULN).
- •Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.
研究组 & 干预措施
500 mg QD
500 mg QD of ANG-3070 will be taken once a day for 10 days.
干预措施: ANG-3070 (Drug)
300 mg BID
300 mg BID of ANG-3070 will be taken twice a day for 10 days.
干预措施: ANG-3070 (Drug)
Placebo-to-match 500 mg QD
Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.
干预措施: Placebo (Drug)
Placebo-to-match 300 mg BID
Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
时间窗: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from 12-lead electrocardiograms (ECGs).
时间窗: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from laboratory test results.
时间窗: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from physical examination.
时间窗: Period 1 Day 1 and Period 2 Day 1
次要结局
未报告次要终点