Clinical trial NCT04567810: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: up to 21 days
Secondary outcomes:
measure: Number of Participants With Vital Sign Findings Reported as TEAEs
timeFrame: up to 21 days
measure: Number of Participants With Clinically Significant Findings in Physical Examinations
timeFrame: up to 21 days
measure: Number of Participants With Clinically Significant Changes From Baseline in ECG Data
timeFrame: up to 21 days
measure: Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
timeFrame: up to 21 days
measure: Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
timeFrame: up to 21 days
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research - Harry Perkins Research Institute
state: Western Australia
Study officials:
affiliation: Stanford University
name: Daria Mochly-Rosen, PhD
role: STUDY_DIRECTOR
affiliation: Linear Clinical Research
name: Michaela Lucas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.