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

NCT04567810 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-07-06

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DRUG

anti-SARS-CoV-2 IgY

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

DRUG

Placebo

Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Sponsors & Collaborators

Principal Investigators

  • Daria Mochly-Rosen, PhD · Stanford University

  • Michaela Lucas, MD · Linear Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2020-12-14
Completion
2020-12-14
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567810 on ClinicalTrials.gov