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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)

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04567810
Collaborator
(none)
48
Enrollment
1
Location
8
Arms
2.9
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: anti-SARS-CoV-2 IgY
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
Dec 14, 2020
Actual Study Completion Date :
Dec 14, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-related adverse events [up to 21 days]

Secondary Outcome Measures

  1. Number of Participants With Vital Sign Findings Reported as TEAEs [up to 21 days]

  2. Number of Participants With Clinically Significant Findings in Physical Examinations [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 [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 [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 [up to 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Linear Clinical Research - Harry Perkins Research Institute Nedlands Western Australia Australia 6009

Sponsors and Collaborators

  • Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT04567810
Other Study ID Numbers:
  • CVR001
First Posted:
Sep 29, 2020
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
COVID-19
Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Jul 6, 2022