Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Covid19

Intervention / Treatment
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* Drug: anti-SARS-CoV-2 IgY
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: 2 mg preparation<br>Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Experimental: Part A: 4 mg preparation<br>Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Experimental: Part A: 8 mg preparation<br>Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Placebo Comparator: Part A: placebo preparation<br>Participants receive placebo matching anti-SARS-CoV-2 IgY. | Drug: Placebo<br>* Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Experimental: Part B: 6 mg total daily dose<br>Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Experimental: Part B: 12 mg total daily dose<br>Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Experimental: Part B: 24 mg total daily dose<br>Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. | Drug: anti-SARS-CoV-2 IgY<br>* anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|
| Placebo Comparator: Part B: 0 mg total daily dose<br>Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days. | Drug: Placebo<br>* Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vital Sign Findings Reported as TEAEs |  | up to 21 days | 
| Number of Participants With Clinically Significant Findings in Physical Examinations | Clinically significant in the judgement of the investigator. | up to 21 days | 
| Number of Participants With Clinically Significant Changes From Baseline in ECG Data | Clinically significant in the judgement of the investigator. | up to 21 days | 
| Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters | Clinically significant in the judgement of the investigator. | up to 21 days | 
| Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY |  | up to 21 days |