NCT07337174尚未招募1 期
A Randomized, Open-label, Single Dose, Two-way, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics After Subcutaneous Injection of HUC2-676 or HUC2-676-R in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Cmax following single-dose administration
研究概览
简要总结
The trial uses a randomized, open-label, single-dose administration per period, and a 2 x 2 crossover design where subjects receive both treatments sequentially with a washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 65 years, inclusive, at screening.
- •Subjects who have been fully informed of the details of this clinical trial, have fully understood the information, have voluntarily decided to participate, and have provided written informed consent to comply with all protocol requirements throughout the trial period.
排除标准
- •Subjects with a current or past clinically significant medical history of hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, or other disorders.
- •For females: Pregnant women (positive urine hCG) or nursing mothers.
研究组 & 干预措施
HUC2-676
Experimental
干预措施: HUC2-676 (Drug)
HUC2-676-R
Active Comparator
干预措施: HUC2-676-R (Drug)
结局指标
主要结局
Cmax following single-dose administration
时间窗: 0 through 72 hours post-dose
AUC following single-dose administration
时间窗: 0 through 72 hours post-dose
次要结局
未报告次要终点
研究者
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