A Phase 2 interventional study of CT-P27 and Placebo in Influenza A, sponsored by Celltrion. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Celltrion · Phase 2, Interventional, and Treatment
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.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 81 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27
Placebo will be administrated once in IV infusion.
Drug: Placebo
Influenza A treatment drug.
Placebo.
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
Time frame: Three times a day from Day 1(the day after virus inoculation) to Day 9
| Milestone | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo |
|---|---|---|---|
| Started | 27 | 27 | 27 |
| Completed | 27 | 27 | 27 |
| Not completed | 0 | 0 | 0 |
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
| Days*Eq log10 TCID50/mL | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo |
|---|---|---|---|
| Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR | 6.474 ± 9.0090 | 6.974 ± 9.0817 | 11.639 ± 9.7982 |
Collected over up to Day 36/end-of-study (EOS) visit. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT-P27 10mg/kg | 0/27 (0%) | 0/27 (0%) | 4/27 (14.8%) |
| CT-P27 20mg/kg | 0/27 (0%) | 0/27 (0%) | 3/27 (11.1%) |
| Placebo | 0/27 (0%) | 0/27 (0%) | 7/27 (25.9%) |
| Event | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 3/27 | 2/27 | 3/27 |
| TachycardiaCardiac disorders | 0/27 | 0/27 | 2/27 |
| Infusion site painGeneral disorders | 0/27 | 0/27 | 1/27 |
| Alanine aminotransferase increasedInvestigations | 1/27 | 0/27 | 1/27 |
| Electrocardiogram QT prolongedInvestigations | 0/27 | 1/27 | 0/27 |
| Lymphocyte count decreasedInvestigations | 0/27 | 1/27 | 0/27 |
| Neutrophil count decreasedInvestigations | 0/27 | 1/27 | 0/27 |
| DysgeusiaNervous system disorders | 0/27 | 0/27 | 1/27 |
| Rash erythematousSkin and subcutaneous tissue disorders | 0/27 | 0/27 | 1/27 |
| HypotensionVascular disorders | 0/27 | 0/27 | 1/27 |
| Age, Continuous(years) | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo | Total |
|---|---|---|---|---|
| Median | 24.0 (20 to 39) | 25.0 (19 to 41) | 25.0 (18 to 42) | 25.0 (18 to 42) |
| Sex: Female, Male(Participants) | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo | Total |
|---|---|---|---|---|
| Female | 10 | 10 | 12 | 32 |
| Male | 17 | 17 | 15 | 49 |
| Race/Ethnicity, Customized(Participants) | CT-P27 10mg/kg | CT-P27 20mg/kg | Placebo | Total |
|---|---|---|---|---|
| White - British | 22 | 23 | 18 | 63 |
| White - Irish | 0 | 1 | 0 | 1 |
| Any other white background | 5 | 2 | 4 | 11 |
| Asian or Asian British - Pakistani | 0 | 1 | 1 | 2 |
| Chinese | 0 | 0 | 1 | 1 |
| Any other Asian background | 0 | 0 | 2 | 2 |
| Any other mixed background | 0 | 0 | 1 | 1 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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