NCT05288881已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers
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
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experienced Treatment-Emergent Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- •Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -
- •Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.
排除标准
- •Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
- •Significant allergies to humanized monoclonal antibodies.
- •Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -
- •Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
- •Have poor venous access limiting phlebotomy.
- •Donation or loss of > 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -
- •Hospitalization during the 4 weeks prior to Screening.
研究组 & 干预措施
ANX105
Experimental
干预措施: ANX105 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced Treatment-Emergent Adverse Events
时间窗: Up to Week 7
次要结局
- Amount of Serum Total Hemolytic Complement (CH50)(Up to Week 7)
- Amount of C1q in Cerebrospinal fluid (CSF)(Up to Week 7)
- Maximum Observed Serum Concentration (Cmax) of ANX105(Up to Week 7)
- Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum(Baseline, Week 7)
- Serum Concentrations of ANX105(Up to Week 7)
- Area Under the ANX105 Serum Concentration-Time Curve (AUC)(Up to Week 7)
- CSF Concentrations of ANX105(Up to Week 7)
研究者
研究点 (2)
Loading locations...
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