Influenza A
Conditions
Keywords
efficacy, safety
Brief summary
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.
Detailed description
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.
Interventions
DRUGCT-P27 90 mg/kg
Influenza A treatment drug.
DRUGCT-P27 45 mg/kg
Influenza A treatment drug.
DRUGPlacebo
Placebo.
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female subjects between the ages of 19 and 64 years, both inclusive * Diagnosed with influenza A at screening using rapid influenza diagnostic test * Onset of influenza symptoms and fever is within 48 hours at screening * At least 2 of symptoms (moderate to severe in intensity) * ≥38.0'C body temperature at screening
Exclusion criteria
* Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug * Positive influenza B or A+B infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resolution of Influenza Symptoms and Fever | Twice a day (Morning and Evening) from Day 1 to Day 8 | Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P27 90 mg/kg CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug. | 88 |
| CT-P27 45mg/kg CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug. | 90 |
| Placebo Placebo will be administrated once in IV infusion.
Placebos: Placebo. | 50 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | CT-P27 90 mg/kg | Total | Placebo | CT-P27 45mg/kg |
|---|---|---|---|---|
| Age, Continuous | 38.5 years | 38.0 years | 34.5 years | 40.0 years |
| Body temperature at screening | 38.1 °C STANDARD_DEVIATION 0.74 | 38.2 °C STANDARD_DEVIATION 0.75 | 38.1 °C STANDARD_DEVIATION 0.65 | 38.3 °C STANDARD_DEVIATION 0.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 228 Participants | 50 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Influenza A confirmation by cell culture or qPCR | 87 Participants | 221 Participants | 48 Participants | 86 Participants |
| Influenza A confirmation Not detected | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Influenza A subtype Influenza A/H1 | 5 Participants | 11 Participants | 4 Participants | 2 Participants |
| Influenza A subtype Influenza A/H3 | 82 Participants | 209 Participants | 44 Participants | 83 Participants |
| Influenza A subtype Not applicable | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Influenza A subtype Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Positive rapid influenza diagnostic test at screening | 88 Participants | 227 Participants | 50 Participants | 89 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 88 Participants | 228 Participants | 50 Participants | 90 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 88 participants | 228 participants | 50 participants | 90 participants |
| Sex: Female, Male Female | 43 Participants | 112 Participants | 26 Participants | 43 Participants |
| Sex: Female, Male Male | 45 Participants | 116 Participants | 24 Participants | 47 Participants |
| Total influenza symptom score at screening | 2.08 Averaged for each symptoms' score | 2.08 Averaged for each symptoms' score | 2.12 Averaged for each symptoms' score | 2.05 Averaged for each symptoms' score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 90 | 0 / 50 |
| other Total, other adverse events | 8 / 88 | 8 / 90 | 6 / 50 |
| serious Total, serious adverse events | 1 / 88 | 5 / 90 | 1 / 50 |
Outcome results
Primary
Time to Resolution of Influenza Symptoms and Fever
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)
Time frame: Twice a day (Morning and Evening) from Day 1 to Day 8
Population: The intent-to-treat-infected (ITTI) population defined as all randomized subjects with confirmed influenza A by quantitative polymerase chain reaction (qPCR) or cell culture.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P27 90 mg/kg | Time to Resolution of Influenza Symptoms and Fever | 3.74 Days |
| CT-P27 45mg/kg | Time to Resolution of Influenza Symptoms and Fever | 3.69 Days |
| Placebo | Time to Resolution of Influenza Symptoms and Fever | 5.72 Days |