A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

Phase 2

Terminated

• Conditions: Influenza A
• Interventions: Drug: CT-P27 90 mg/kg; Drug: CT-P27 45 mg/kg; Drug: Placebo

• Registration Number: NCT03511066
• Lead Sponsor: Celltrion

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.

Study Timeline

• Study Start: 2016-12-09
• Study First Submitted: 2018-02-28
• Primary Completion: 2018-03-09
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-27
• Study Completion: 2018-06-15
• Results First Submitted: 2020-02-28
• Status Verified: 2022-08
• Results First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-28
• Results First Posted: 2022-10-31
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P27 90 mg/kg	CT-P27 90 mg/kg	CT-P27 will be administrated once in IV infusion.
CT-P27 45mg/kg	CT-P27 45 mg/kg	CT-P27 will be administrated once in IV infusion.
Placebo	Placebo	Placebo will be administrated once in IV infusion.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of