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This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P27 10mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. |
|
| CT-P27 20mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. |
|
| Placebo | Placebo Comparator | Placebo will be administrated once in IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P27 | Drug | Influenza A treatment drug. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR | AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine | Three times a day from Day 1(the day after virus inoculation) to Day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SuEun Song | Celltrion Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retroscreen Virology Ltd. | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P27 10mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 10 mg/kg: Influenza A treatment drug. |
| FG001 | CT-P27 20mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 20 mg/kg: Influenza A treatment drug. |
| FG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P27 10mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 10 mg/kg: Influenza A treatment drug. |
| BG001 | CT-P27 20mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 20 mg/kg: Influenza A treatment drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR | AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine | The Infected Population included all subjects in the Efficacy Population who provided at least 2 positive nasopharyngeal swabs within 24 h when tested using quantitative PCR assay. | Posted | Mean | Standard Deviation | Days*Eq log10 TCID50/mL | Three times a day from Day 1(the day after virus inoculation) to Day 9 |
|
up to Day 36/end-of-study (EOS) visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P27 10mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 10 mg/kg: Influenza A treatment drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders |
Serious Adverse Events and Other (Not Including Serious) Adverse Events are treatment-emergent adverse events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning Department | Celltrion | 82328505000 | contact@celltrion.com |
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| Placebo |
| Drug |
Placebo. |
|
| BG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
CT-P27 will be administrated once in IV infusion.
CT-P27 20 mg/kg: Influenza A treatment drug.
| OG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 4 |
| 27 |
| EG001 | CT-P27 20mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 20 mg/kg: Influenza A treatment drug. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. | 0 | 27 | 0 | 27 | 7 | 27 |
| Infusion site pain | General disorders |
|
| Alanine aminotransferase increased | Investigations |
|
| Electrocardiogram QT prolonged | Investigations |
|
| Lymphocyte count decreased | Investigations |
|
| Neutrophil count decreased | Investigations |
|
| Headache | Nervous system disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Rash erythematous | Skin and subcutaneous tissue disorders |
|
| Hypotension | Vascular disorders |
|
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