Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model (NCT NCT02071914)
NCT ID: NCT02071914
Last Updated: 2020-04-08
Results Overview
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Three times a day from Day 1(the day after virus inoculation) to Day 9
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
CT-P27 10mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 10 mg/kg: Influenza A treatment drug.
|
CT-P27 20mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 20 mg/kg: Influenza A treatment drug.
|
Placebo
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Baseline characteristics by cohort
| Measure |
CT-P27 10mg/kg
n=27 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 10 mg/kg: Influenza A treatment drug.
|
CT-P27 20mg/kg
n=27 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 20 mg/kg: Influenza A treatment drug.
|
Placebo
n=27 Participants
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.0 years
n=99 Participants
|
25.0 years
n=107 Participants
|
25.0 years
n=206 Participants
|
25.0 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White - British
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White - Irish
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Any other white background
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British - Pakistani
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Any other Asian background
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Any other mixed background
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Three times a day from Day 1(the day after virus inoculation) to Day 9Population: 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.
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
Outcome measures
| Measure |
CT-P27 10mg/kg
n=20 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 10 mg/kg: Influenza A treatment drug.
|
CT-P27 20mg/kg
n=20 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 20 mg/kg: Influenza A treatment drug.
|
Placebo
n=21 Participants
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
|
6.474 Days*Eq log10 TCID50/mL
Standard Deviation 9.0090
|
6.974 Days*Eq log10 TCID50/mL
Standard Deviation 9.0817
|
11.639 Days*Eq log10 TCID50/mL
Standard Deviation 9.7982
|
Adverse Events
CT-P27 10mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CT-P27 20mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT-P27 10mg/kg
n=27 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 10 mg/kg: Influenza A treatment drug.
|
CT-P27 20mg/kg
n=27 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 20 mg/kg: Influenza A treatment drug.
|
Placebo
n=27 participants at risk
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
7.4%
2/27 • up to Day 36/end-of-study (EOS) visit
|
|
General disorders
Infusion site pain
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • up to Day 36/end-of-study (EOS) visit
|
7.4%
2/27 • up to Day 36/end-of-study (EOS) visit
|
11.1%
3/27 • up to Day 36/end-of-study (EOS) visit
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
0.00%
0/27 • up to Day 36/end-of-study (EOS) visit
|
3.7%
1/27 • up to Day 36/end-of-study (EOS) visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER