A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Trial to Evaluate 150 mg Subcutaneous CIT-013 Administration in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Citryll BV
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a phase 1, double-blind, randomized, placebo-controlled, single center, repeat-dose trial for the assessment of safety, tolerability, bioavailability and pharmacokinetic profiles of 150 mg CIT-013 in healthy adult volunteers
详细描述
The active treatment in this trial is CIT-013, an investigational medicinal product that will be administered at a fixed dose level of 150 mg, subcutaneous (one 50 mg and one 100 mg injection), and is compared against placebo. CIT-013 is an IgG1k monoclonal antibody consisting of two identical light chain polypeptides composed of 219 amino acids each and two identical heavy chain polypeptides composed of 451 amino acids each. CIT-013 and placebo will be administered via subcutaneous injection in the abdominal wall.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women, 18 to 75 years of age (inclusive) at screening.
排除标准
- •Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the trial, or that would pose an unacceptable risk to the participant in the opinion of the Investigator.
研究组 & 干预措施
CIT-013 high dose
CIT-013 high dose
干预措施: CIT-013 high dose (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 6 weeks
Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings, and antidrug antibody (ADA) results.
次要结局
未报告次要终点