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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Covid19

Treatments: Drug: Placebo; Drug: anti-SARS-CoV-2 IgY

Study type: Interventional

Funder types: Other

Identifiers

NCT04567810

CVR001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

48 participants in 8 patient groups, including a placebo group

Part A: 2 mg preparation

Experimental group

Description:

Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part A: 4 mg preparation

Experimental group

Description:

Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part A: 8 mg preparation

Experimental group

Description:

Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part A: placebo preparation

Placebo Comparator group

Description:

Participants receive placebo matching anti-SARS-CoV-2 IgY.

Treatment:

Drug: Placebo

Part B: 6 mg total daily dose

Experimental group

Description:

Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part B: 12 mg total daily dose

Experimental group

Description:

Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part B: 24 mg total daily dose

Experimental group

Description:

Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Treatment:

Drug: anti-SARS-CoV-2 IgY

Part B: 0 mg total daily dose

Placebo Comparator group

Description:

Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.

Treatment:

Drug: Placebo