NCT03511066

A Study to Evaluate the Efficacy and Safety of CT-P27 in 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: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	CT-P27 90 mg/kg	Influenza A treatment drug.
DRUG	CT-P27 45 mg/kg	Influenza A treatment drug.
DRUG	Placebo	Placebo.

Timeline

• Start date: 2016-12-09
• Primary completion: 2018-03-09
• Completion: 2018-06-15
• First posted: 2018-04-27
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study