NCT05349760撤回2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
IRT and unblinded pharmacists
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
- •Subjects ≥40 years old.
- •History of confirmed diagnosis of IPF
- •Chest HRCT at Screening
- •Subjects who are either:
- •Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
- •Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
- •Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
- •Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
- •Has adequate hematologic, hepatic, and renal function
排除标准
- •Prior investigational drug use within 30 days or 5 half-lives
- •Presence of emphysema exceeding the extent of fibrosis
- •Active or anticipated need for lung transplant
- •Treatment with prednisone
- •Active cancer
- •Active or chronic infection with HCV, HBV, or HIV
- •Known active tuberculosis
- •History of or current immunosuppressive condition
- •IPF exacerbation within 12 weeks
- •Lower respiratory-tract infection requiring antibiotic therapy
- •Other forms of interstitial lung disease
- •History of lung volume reduction surgery or lung transplant
- •Contraindications for forced expiratory maneuvers during spirometry
- •Unstable cardiac or pulmonary disease (other than IPF)
- •Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
- •History of drug or alcohol abuse -
研究组 & 干预措施
AMB-05X
Experimental
AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
干预措施: AMB-05X (Biological)
Placebo
Placebo Comparator
Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events
时间窗: Week 24
Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale
次要结局
- Pulmonary Function(Week 28)
- ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)(Week 28)
- Pharmacodynamics via CSF1(Week 28)
- Cmax(Week 24)
- AUC(Week 24)
研究者
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