NCT07577479进行中（未招募）1 期
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
Shanghai Argo Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年5月18日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
详细描述
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- •Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- •Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- •Male participants with partners of childbearing potential must agree to use effective contraception.
排除标准
- •Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
- •Recent hospitalization or a significant acute medical event.
- •History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
- •Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -
- •Positive test for hepatitis B, hepatitis C, or HIV.
研究组 & 干预措施
BW-50218 Dose 3
Experimental
Single dose of BW-50218 injection (Dose 3)
干预措施: BW-50218 Injection (Drug)
Saline Placebo
Placebo Comparator
Single dose of Saline Placebo
干预措施: Saline (0.9% NaCl) (Drug)
BW-50218 Dose1
Experimental
Single dose of BW-50218 injection (Dose 1)
干预措施: BW-50218 Injection (Drug)
BW-50218 Dose 2
Experimental
Single dose of BW-50218 injection (Dose 2)
干预措施: BW-50218 Injection (Drug)
研究者
研究点 (1)
Loading locations...
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