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This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC-Ad6-1 Low Dose Intramuscular | Experimental | Low Dose SC-Ad6-1, I.M., single-dose (Day 1) |
|
| SC-Ad6-1 Medium Dose Intramuscular | Experimental | Medium Dose SC-Ad6-1, I.M., single-dose (Day 1) |
|
| SC-Ad6-1 High Dose #1 Intramuscular | Experimental | High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1) |
|
| SC-Ad6-1 High Dose #2 Intramuscular | Experimental | High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1) |
|
| SC-Ad6-1 Multiple Dose Intramuscular | Experimental | Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22) |
|
| SC-Ad6-1 High Dose #3 Intramuscular Booster | Experimental | High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC-Ad6-1 | Biological | SC-Ad6-1, I.M., single or multiple-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose | Solicited local adverse events are defined as pain, redness and swelling at the site of dose administration for the intramuscular arms, are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms and are defined as stuffy nose, runny nose, dry mouth, mouth sores, sore or scratchy throat and cough for the inhalation arms. Solicited systemic adverse events for all routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills. | 7 days following each dose |
| Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons | Up to 106 days following first dose | |
| Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay | Up to 106 days following first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA) | Up to 106 days following first dose | |
| Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell Rother, Ph.D. | Moat Biotechnology Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tetherex Study Site | Brisbane | Queensland | Australia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| SC-Ad6-1 Low Dose Intranasal | Experimental | Low Dose SC-Ad6-1, I.N., single-dose (Day 1) |
|
| SC-Ad6-1 Medium Dose Intranasal | Experimental | Medium Dose SC-Ad6-1, I.N., single-dose (Day 1) |
|
| SC-Ad6-1 High Dose #1 Intranasal | Experimental | High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1) |
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| SC-Ad6-1 High Dose #2 Intranasal | Experimental | High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1) |
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| SC-Ad6-1 Multiple Dose Intranasal | Experimental | Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22) |
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| SC-Ad6-1 High Dose #3 Intranasal Booster | Experimental | High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1) |
|
| SC-Ad6-1 High Dose #4 Intranasal Booster | Experimental | High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1) |
|
| SC-Ad6-1 Low Dose Inhaled | Experimental | Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1) |
|
| SC-Ad6-1 Medium Dose Inhaled | Experimental | Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1) |
|
| SC-Ad6-1 Multiple High Dose Intranasal | Experimental | Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29) |
|
| SC-Ad6-1 Multiple High Dose Inhaled | Experimental | Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29) |
|
| SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled | Experimental | Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29) |
|
| SC-Ad6-1 | Biological | SC-Ad6-1, I.N., single or multiple-dose |
|
| SC-Ad6-1 | Biological | SC-Ad6-1, I.H., single or multiple-dose |
|
| Up to 106 days following first dose |
| Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot) | Up to 106 days following first dose |
| Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA)) | Up to 106 days following first dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |