A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single -Ascending and Multiple Doses of an Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY)
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
- Number of participants with treatment-related adverse events
研究概览
简要总结
The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants.
The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants.
Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating females
- •Body weight of at least 50 kg
- •Good state of health (mentally and physically)
- •Must agree to use of highly effective method of contraception
排除标准
- •Received other investigational drug within the last 30 days prior to screening
- •History of drug or alcohol abuse in the past 2 years (>21 units of alcohol per week for males and >14 units of alcohol per week for females)
- •Current smoker / e-smoker
- •Abnormal kidney function
- •Abnormal liver function
- •Positive for hepatitis B or C infection
- •Positive for HIV infection
- •Positive for SARS-CoV-2 infection
- •History of egg allergy
- •Abnormal cardiac function
研究组 & 干预措施
Part A: 2 mg preparation
Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part A: 4 mg preparation
Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part A: 8 mg preparation
Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part A: placebo preparation
Participants receive placebo matching anti-SARS-CoV-2 IgY.
干预措施: Placebo (Drug)
Part B: 6 mg total daily dose
Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part B: 12 mg total daily dose
Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part B: 24 mg total daily dose
Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
干预措施: anti-SARS-CoV-2 IgY (Drug)
Part B: 0 mg total daily dose
Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: up to 21 days
次要结局
- Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY(up to 21 days)
- Number of Participants With Vital Sign Findings Reported as TEAEs(up to 21 days)
- Number of Participants With Clinically Significant Findings in Physical Examinations(up to 21 days)
- Number of Participants With Clinically Significant Changes From Baseline in ECG Data(up to 21 days)
- Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters(up to 21 days)