A phase IIb study to investigate the efficacy and safety of CT-P27 in subject with Acute uncomplicated influenza A infection

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002211

Enrollment

210

Registered

2017-02-03

Start date

2016-12-09

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Subjects will receive the IP according to assigned group which is randomized into one of the 3 groups (CT-P27 A group, CT-P27 B group, and Placebo) as 1:1:1 ratio.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy of CT-P27; Resolution of symptons of influenza and fever	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactJoonYoung Song

Koera University Guro Hospital

Outcome results