NCT06872112招募中1 期
Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Joseph C. Wu1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年1月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must meet the following criteria to be enrolled in this study:
- •Adults aged 18 to 75 years.
- •WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.
排除标准
- •Participants who meet any of the following criteria will be excluded from the study.
- •Participants with serious concomitant morbidity per investigator assessment.
研究组 & 干预措施
Open Label Treatment Arm
Experimental
Dose escalating study with a Follow-up (washout) Period:
Total study period of the open-label study: 14 weeks Screening Period: up to 4 weeks Treatment Period (20 mg TID): 4 weeks Treatment Period (40 mg TID): 4 weeks Treatment Period (60 mg TID): 4 weeks Follow-up (washout) Period: 2 weeks after treatment period ends
干预措施: Artesunate (Drug)
结局指标
主要结局
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
Joseph C. Wu
Director, Stanford Cardiovascular Institute
Stanford University
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
An Exploratory Clinical Trial of Autologous Humanized Anti-cluster of Differentiation Antigen 19/20(CD19/CD20) Dual Specific CAR-T Cells InjectionDiffuse Large B Cell LymphomaNCT04486872First Affiliated Hospital of Zhejiang University18
招募中
1 期
Safety of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Diffuse Large B-cell LymphomaRelapsed or Refractory DLBCL Patients With Either CD19 or CD20 PositiveNCT04215016Fujian Medical University18
终止
1 期
Safety and Efficacy of HMI-103 in Participants With Classical PKU Due to PAH DeficiencyPhenylketonuriasPAH DeficiencyPhenylketonuriaNCT05222178Homology Medicines, Inc3
招募中
1 期
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 MutationSolid TumorNCT03781219Shanghai Kechow Pharma, Inc.45
Unknown
1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid TumorsSolid TumorNCT03757936Shanghai Henlius Biotech30