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Completed

NCT Number: NCT04567810

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research - Harry Perkins Research Institute

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-SARS-CoV-2 IgY

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: up to 21 days

Secondary outcomes

  1. Number of Participants With Vital Sign Findings Reported as TEAEs

    Time frame: up to 21 days

  2. Number of Participants With Clinically Significant Findings in Physical Examinations

    Time frame: up to 21 days

    Clinically significant in the judgement of the investigator.

  3. Number of Participants With Clinically Significant Changes From Baseline in ECG Data

    Time frame: up to 21 days

    Clinically significant in the judgement of the investigator.

  4. Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

    Time frame: up to 21 days

    Clinically significant in the judgement of the investigator.

  5. Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY

    Time frame: up to 21 days

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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