A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Plasma concentrations of ZSP1603
研究概览
简要总结
This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded
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
- •IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management;
- •Dlco (corrected for Hb): 30%-79% predicted of normal;
- •FVC>= 50% predicted of normal;
排除标准
- •FEV1/FVC< 0.7;
- •PaO2 in resting state without oxygen inhalation < 50mmHg;
- •Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator;
- •Poorly controlled cardiovascular and cerebrovascular diseases;
- •Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone > 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment;
研究组 & 干预措施
part1:ZSP1603 dose1
干预措施: ZSP1603 (Drug)
part1:ZSP1603 dose2
干预措施: ZSP1603 (Drug)
part1:ZSP1603 dose3
干预措施: ZSP1603 (Drug)
Part2: ZSP1603 dose
干预措施: ZSP1603 (Drug)
Part2: placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma concentrations of ZSP1603
时间窗: up to 15 Days
Pharmacokinetic analysis
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: up to 16 weeks
TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
次要结局
- Change in FVC From Baseline at 12 weeks(up to 12 weeks)
- Change in FVC%Pred from baseline at 12 weeks(up to12 weeks)