NCT05901883已完成1 期
A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CEL383 When Administered Intravenously to Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female (of nonchildbearing potential only), 19-64 years of age, inclusive, at screening visit
- •Willingness of men of reproductive potential to agree to use a condom with spermicide or abstain from heterosexual intercourse from dosing until at least 90 days after dosing
- •Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening visit
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- •History or presence of alcohol or drug abuse within the past 2 years prior to dosing
- •History or presence of any known primary or secondary immunodeficiency disorder
- •History or presence of any signs, symptoms, or diagnosis of infection, including nausea, vomiting, fever, rash, confusion, muscle aches, cough, nasal congestion, or shortness of breath, in the 4 weeks prior to screening or during the screening period.
- •History or presence of any known clotting or hemostasis disorder
- •Female subject of childbearing potential
研究组 & 干预措施
CEL383 Arm
Experimental
Subjects will receive a single intravenous dose of CEL383
干预措施: CEL383 (Drug)
Placebo Arm
Placebo Comparator
Subjects will receive a single intravenous dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs)
时间窗: Through the Day 85 study visit
Incidence of TEAEs by type, severity, seriousness, and relationship
次要结局
- t1/2(Day 1 through Day 85)
- Cmax(Day 1 through Day 85)
- Tmax(Day 1 through Day 85)
- AUC(Day 1 through Day 85)
- ADA(Day 1 through Day 85)
研究者
研究点 (1)
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