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A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02071914
Enrollment
81
Registered
2014-02-26
Start date
2014-02-15
Completion date
2014-06-19
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A

Keywords

efficacy, safety

Brief summary

This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

Detailed description

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.

Interventions

DRUGCT-P27

Influenza A treatment drug.

DRUGPlacebo

Placebo.

Sponsors

Celltrion
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy Male & Female volunteers

Exclusion criteria

* Current clinically significant disease * Pregnant or nursing mother * Abnormal pulmonary function, nose or nasopharynx

Design outcomes

Primary

MeasureTime frameDescription
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCRThree times a day from Day 1(the day after virus inoculation) to Day 9AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
CT-P27 10mg/kg
CT-P27 will be administrated once in IV infusion. CT-P27 10 mg/kg: Influenza A treatment drug.
27
CT-P27 20mg/kg
CT-P27 will be administrated once in IV infusion. CT-P27 20 mg/kg: Influenza A treatment drug.
27
Placebo
Placebo will be administrated once in IV infusion. Placebos: Placebo.
27
Total81

Baseline characteristics

CharacteristicCT-P27 10mg/kgCT-P27 20mg/kgPlaceboTotal
Age, Continuous24.0 years25.0 years25.0 years25.0 years
Race/Ethnicity, Customized
Any other Asian background
0 Participants0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Any other mixed background
0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Any other white background
5 Participants2 Participants4 Participants11 Participants
Race/Ethnicity, Customized
Asian or Asian British - Pakistani
0 Participants1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Chinese
0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White - British
22 Participants23 Participants18 Participants63 Participants
Race/Ethnicity, Customized
White - Irish
0 Participants1 Participants0 Participants1 Participants
Sex: Female, Male
Female
10 Participants10 Participants12 Participants32 Participants
Sex: Female, Male
Male
17 Participants17 Participants15 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 270 / 27
other
Total, other adverse events
4 / 273 / 277 / 27
serious
Total, serious adverse events
0 / 270 / 270 / 27

Outcome results

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

Time frame: Three times a day from Day 1(the day after virus inoculation) to Day 9

Population: 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.

ArmMeasureValue (MEAN)Dispersion
CT-P27 10mg/kgViral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR6.474 Days*Eq log10 TCID50/mLStandard Deviation 9.009
CT-P27 20mg/kgViral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR6.974 Days*Eq log10 TCID50/mLStandard Deviation 9.0817
PlaceboViral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR11.639 Days*Eq log10 TCID50/mLStandard Deviation 9.7982

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026