NCT07439796招募中1 期
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
Orna Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月16日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- •Male and female participants who are healthy as determined by the Investigator based on review of medical history, physical examination, and laboratory tests
- •Participant is willing and able to comply with study visits and other protocol requirements
- •Other protocol specific inclusion criteria may apply
排除标准
- •Clinically significant history or presence of organ dysfunction
- •Use of any investigational product within 3 months, or 5 half-lives, whichever longer
- •Other protocol specific exclusion criteria may apply
研究组 & 干预措施
Single Ascending Dose
Experimental
Ascending single dose of ORN252 on a specified day
干预措施: ORN252 (Biological)
结局指标
主要结局
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
时间窗: 12 weeks
To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.
次要结局
- Pharmacokinetic (PK) parameters of ORN252 components(29 days)
- Pharmacodynamic (PD) effects of of ORN252(12 weeks)
- Immunogenicity of ORN252(12 weeks)
研究者
研究点 (1)
Loading locations...
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