A phase IIb study to investigate the efficacy and safety of CT-P27 in subject with Acute uncomplicated influenza A infectio
Not Applicable
Recruiting
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0002211
- Lead Sponsor
- Celltrion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
• Written informed consent.
• Onset of illness no more than 48 hours prior to the planned administration of study drug.
• Diagnosed with influenza A at screening.
Exclusion Criteria
• Positive influenza B or invluenza A+B infection
Previous exposure to any anti-influenza monoclonal antibody therapy including CT-P27 prior to study drug administration.
• Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug.
•Immunized against influenza with live attenuated or inactivated virus vaccine within 21 days prior to the administration of study drug.
• Abnormal pulmonary, renal, cardiac function
• Pregnant or nursing mother
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of CT-P27; Resolution of symptons of influenza and fever
- Secondary Outcome Measures
Name Time Method Safety of CT-P27; Treatment-Emergent Adverse Event, Treatment-Emergent Serious Adverse Event;Immunogenicity assessment of CT-P27 ;Genotype and phenotype of isolated influenza virus ;Pharmacokinetics of CT-P27 components (CT-P22 and CT-P23) and assessment of anti-influenza antibodies (only for PK sub-group)