Back to resultsSafety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
anti-SARS-CoV-2 IgY
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Linear Clinical Research - Harry Perkins Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Part A: 2 mg preparation
Part A: 4 mg preparation
Part A: 8 mg preparation
Part A: placebo preparation
Part B: 6 mg total daily dose
Part B: 12 mg total daily dose
Part B: 24 mg total daily dose
Part B: 0 mg total daily dose
Arm Description
Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.
Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.
Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.
Participants receive placebo matching anti-SARS-CoV-2 IgY.
Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events
Secondary Outcome Measures
Number of Participants With Vital Sign Findings Reported as TEAEs
Number of Participants With Clinically Significant Findings in Physical Examinations
Clinically significant in the judgement of the investigator.
Number of Participants With Clinically Significant Changes From Baseline in ECG Data
Clinically significant in the judgement of the investigator.
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Clinically significant in the judgement of the investigator.
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04567810
Brief Title
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: 2 mg preparation
Arm Type
Experimental
Arm Description
Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.
Arm Title
Part A: 4 mg preparation
Arm Type
Experimental
Arm Description
Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.
Arm Title
Part A: 8 mg preparation
Arm Type
Experimental
Arm Description
Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.
Arm Title
Part A: placebo preparation
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo matching anti-SARS-CoV-2 IgY.
Arm Title
Part B: 6 mg total daily dose
Arm Type
Experimental
Arm Description
Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Arm Title
Part B: 12 mg total daily dose
Arm Type
Experimental
Arm Description
Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Arm Title
Part B: 24 mg total daily dose
Arm Type
Experimental
Arm Description
Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
Arm Title
Part B: 0 mg total daily dose
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
anti-SARS-CoV-2 IgY
Intervention Description
anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
Number of Participants With Vital Sign Findings Reported as TEAEs
Time Frame
up to 21 days
Title
Number of Participants With Clinically Significant Findings in Physical Examinations
Description
Clinically significant in the judgement of the investigator.
Time Frame
up to 21 days
Title
Number of Participants With Clinically Significant Changes From Baseline in ECG Data
Description
Clinically significant in the judgement of the investigator.
Time Frame
up to 21 days
Title
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Description
Clinically significant in the judgement of the investigator.
Time Frame
up to 21 days
Title
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Time Frame
up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daria Mochly-Rosen, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michaela Lucas, MD
Organizational Affiliation
Linear Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linear Clinical Research - Harry Perkins Research Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35720389
Citation
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.
Results Reference
result
PubMed Identifier
34473343
Citation
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.
Results Reference
derived
Learn more about this trial
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
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