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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Linear Clinical Research - Harry Perkins Research Institute
Nedlands, Western Australia, Australia
Number of participants with treatment-related adverse events
Time frame: up to 21 days
Number of Participants With Vital Sign Findings Reported as TEAEs
Time frame: up to 21 days
Number of Participants With Clinically Significant Findings in Physical Examinations
Clinically significant in the judgement of the investigator.
Time frame: up to 21 days
Number of Participants With Clinically Significant Changes From Baseline in ECG Data
Clinically significant in the judgement of the investigator.
Time frame: up to 21 days
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Clinically significant in the judgement of the investigator.
Time frame: up to 21 days
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Time frame: up to 21 days
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