Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
- Registration Number
- NCT04567810
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: placebo preparation Placebo Participants receive placebo matching anti-SARS-CoV-2 IgY. Part B: 0 mg total daily dose Placebo Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days. Part A: 2 mg preparation anti-SARS-CoV-2 IgY Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY. Part A: 8 mg preparation anti-SARS-CoV-2 IgY Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY. Part B: 6 mg total daily dose anti-SARS-CoV-2 IgY Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. Part A: 4 mg preparation anti-SARS-CoV-2 IgY Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY. Part B: 24 mg total daily dose anti-SARS-CoV-2 IgY Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. Part B: 12 mg total daily dose anti-SARS-CoV-2 IgY Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events up to 21 days
- Secondary Outcome Measures
Name Time Method 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 Clinically significant in the judgement of the investigator.
Number of Participants With Clinically Significant Changes From Baseline in ECG Data up to 21 days Clinically significant in the judgement of the investigator.
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY up to 21 days Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters up to 21 days Clinically significant in the judgement of the investigator.
Trial Locations
- Locations (1)
Linear Clinical Research - Harry Perkins Research Institute
🇦🇺Nedlands, Western Australia, Australia