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

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)

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: anti-SARS-CoV-2 IgY; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research - Harry Perkins Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Daria Mochly-Rosen, PhD, Stanford University; Principal Investigator: Michaela Lucas, MD, Linear Clinical Research

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
• Frumkin LR, Lucas M, Scribner CL, Ortega-Heinly N, Rogers J, Yin G, Hallam TJ, Yam A, Bedard K, Begley R, Cohen CA, Badger CV, Abbasi SA, Dye JM, McMillan B, Wallach M, Bricker TL, Joshi A, Boon ACM, Pokhrel S, Kraemer BR, Lee L, Kargotich S, Agochiya M, John TS, Mochly-Rosen D. Egg-Derived Anti-SARS-CoV-2 Immunoglobulin Y (IgY) With Broad Variant Activity as Intranasal Prophylaxis Against COVID-19. Front Immunol. 2022 Jun 1;13:899617. doi: 10.3389/fimmu.2022.899617. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: CVR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes