jRCT2051240229招募中不适用
A PHASE 1/2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Basic Science
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •diagnosis of pulmonary arterial hypertension (PAH)
- •stable dose of standard of care PAH vasodilators
- •BMI 16 to 32 kg/m2; and a total body weight >45 kg.
- •6MWD >= 150 and <=
- •Pre-randomization RHC documenting a minimum of PVR >= 400 dyn *sec/cm5.
排除标准
- •Any medical or psychiatric condition or laboratory abnormality.
- •Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day
- •Pulmonary capillary wedge pressure > 15 mmHg on right heart catheterization (RHC) conducted during Screening.
- •History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
- •Major surgery within 8 weeks prior to randomization.
- •Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history >=10 pack-years.
研究者
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