Covid19
Conditions
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.
Interventions
DRUGanti-SARS-CoV-2 IgY
anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
DRUGPlacebo
Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | up to 21 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vital Sign Findings Reported as TEAEs | up to 21 days | — |
| Number of Participants With Clinically Significant Findings in Physical Examinations | up to 21 days | Clinically significant in the judgement of the investigator. |
| Number of Participants With Clinically Significant Changes From Baseline in ECG Data | up to 21 days | Clinically significant in the judgement of the investigator. |
| 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. |
| Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY | up to 21 days | — |
Countries
Australia
Outcome results
None listed