NCT07221513撤回2 期
A Phase 2a, Open-Label Study to Assess the Safety, Tolerability, and Efficacy of JK07 in Participants With Heart Failure and Group 2 Combined Post-Capillary and Pre-Capillary Pulmonary Hypertension (RENEU-PH)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of TEAEs [Safety and tolerability]
研究概览
简要总结
This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH.
At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with HF New York Heart Association Class II-III.
- •Participants will be classified as having HFrEF (LVEF ≤ 40%) or HFpEF (LVEF >40% and ≤70%).
- •Right heart catheterization (RHC) based evidence of cpcPH:
- •PVR ≥2.5 WU; AND
- •mPAP ≥25 mmHg; AND
- •PAWP ≥16 mmHg
排除标准
- •Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group
- •Contraindicated to RHC that can be left in place for approximately 6 hours.
- •A diagnosis of pre-existing lung disease including congenital abnormalities, full or partial pneumonectomy, or previous therapeutic radiation of lungs or mediastinum.
- •Body mass index (BMI) >45 kg/m² at screening.
研究组 & 干预措施
JK07 high dose
Experimental
JK07 administered by intravenous (IV) infusion
干预措施: JK07 (Drug)
结局指标
主要结局
Incidence and severity of TEAEs [Safety and tolerability]
时间窗: Study entry through week 26
Incidence and severity of treatment emergent adverse events
次要结局
- Pharmacokinetic - Cmax(Study entry through week 26)
- Pharmacokinetics - Tmax(Study entry through week 26)
- Pharmacokinetics - AUC0-last(Study entry through week 26)
- Pharmacokinetics - AUC0-inf(Study entry through week 26)
- Pharmacokinetics - t1/2(Study entry through week 26)
- Pharmacokinetics - λz(Study entry through week 26)
- Pharmacokinetics - CL(Study entry through week 26)
- Pharmacokinetics - Vz(Study entry through week 26)
研究者
研究点 (1)
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