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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 2 mg preparation | Experimental | Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY. |
|
| Part A: 4 mg preparation | Experimental | Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY. |
|
| Part A: 8 mg preparation | Experimental | Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY. |
|
| Part A: placebo preparation | Placebo Comparator | Participants receive placebo matching anti-SARS-CoV-2 IgY. |
|
| Part B: 6 mg total daily dose | Experimental | Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. |
|
| Part B: 12 mg total daily dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-SARS-CoV-2 IgY | Drug | anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vital Sign Findings Reported as TEAEs | up to 21 days | |
| Number of Participants With Clinically Significant Findings in Physical Examinations | Clinically significant in the judgement of the investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daria Mochly-Rosen, PhD | Stanford University | Study Director |
| Michaela Lucas, MD | Linear Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research - Harry Perkins Research Institute | Nedlands | Western Australia | 6009 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35720389 | Result | Frumkin LR, Lucas M, Scribner CL, Ortega-Heinly N, Rogers J, Yin G, Hallam TJ, Yam A, Bedard K, Begley R, Cohen CA, Badger CV, Abbasi SA, Dye JM, McMillan B, Wallach M, Bricker TL, Joshi A, Boon ACM, Pokhrel S, Kraemer BR, Lee L, Kargotich S, Agochiya M, John TS, Mochly-Rosen D. Egg-Derived Anti-SARS-CoV-2 Immunoglobulin Y (IgY) With Broad Variant Activity as Intranasal Prophylaxis Against COVID-19. Front Immunol. 2022 Jun 1;13:899617. doi: 10.3389/fimmu.2022.899617. eCollection 2022. | |
| 34473343 |
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Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
|
| Part B: 24 mg total daily dose | Experimental | Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. |
|
| Part B: 0 mg total daily dose | Placebo Comparator | Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days. |
|
| Placebo | Drug | Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper. |
|
| up to 21 days |
| Number of Participants With Clinically Significant Changes From Baseline in ECG Data | Clinically significant in the judgement of the investigator. | 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. | up to 21 days |
| Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY | up to 21 days |
| Derived |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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