NCT07768176尚未招募1 期
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PTT-121 After Single and Multiple Ascending Doses in Healthy Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
This is a Phase I, single-center, randomized, double-blind, placebo-controlled SAD/MAD study to evaluate safety, tolerability, and PK of Intravenously Administered PTT-121 in healthy Chinese adults.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged between 18 and 55 years.
- •BMI 18.0-26.
- •Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc.
排除标准
- •History of any clinically significant disease or disorder of the cardiovascular, respiratory, gastrointestinal, genitourinary, hematologic/lymphatic, neurologic, reproductive, psychiatric, endocrine, immunologic, musculoskeletal, breast, ear, ocular, thyroid, neoplastic, metabolic, or dermatologic systems, as determined by the Investigator.
- •History of hypersensitivity to the active ingredient of the investigational product, any of its excipients, or related compounds; or a history of severe drug-induced allergic reactions, including but not limited to angioedema and bronchospasm/asthma.
研究组 & 干预措施
PTT-121 treatment
Experimental
干预措施: PTT-121 (Drug)
Placebo treatment
Placebo Comparator
干预措施: PTT-121 placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: SAD: up to 15 days MAD: up to 21 days
次要结局
- Pharmacokinetics of PTT-121(SAD: up to 2 days MAD: up to 7 days)
研究者
研究点 (1)
Loading locations...
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