NCT05521269已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteer
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
- 135
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in 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
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.
- •MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.
排除标准
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.
- •History of any autoimmune disease
- •History of meningitis or septicemia
- •Clinically significant infection within 30 days prior to study drug administration that required medical intervention
- •Known genetic deficiencies of the complement cascade system or immunodeficiency.
- •Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
- •Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .
- •History of prior other malignancy that could affect compliance with the protocol or interpretation of results
- •Has clinically significant laboratory abnormalities or abnormal ECG
- •History of splenectomy.
- •Antinuclear antibodies titer ≥1:160 at Screening.
- •Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.
研究组 & 干预措施
ANX1502 SAD
Experimental
Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
干预措施: ANX1502 (Drug)
ANX1502 SAD
Experimental
Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
干预措施: Placebo (Drug)
ANX1502 MAD
Experimental
Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
干预措施: ANX1502 (Drug)
ANX1502 MAD
Experimental
Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
时间窗: Day 1 (after dosing) through Day 29
次要结局
- Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502(Predose up Day 29)
- Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502(Predose up Day 29)
- Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502(Predose up to Day 29)
- Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502(Predose up Day 29)
- Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502(Predose up to Day 29)
研究者
研究点 (1)
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