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

Celltrion Healthcare

Status and phase: Terminated; Phase 2

Conditions: Influenza A

Treatments: Drug: Placebo; Drug: CT-P27 45 mg/kg; Drug: CT-P27 90 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03511066

CT-P27 2.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 3 patient groups, including a placebo group

CT-P27 90 mg/kg

Experimental group

Description:

CT-P27 will be administrated once in IV infusion.

Treatment:

Drug: CT-P27 90 mg/kg

CT-P27 45mg/kg

Experimental group

Description:

CT-P27 will be administrated once in IV infusion.

Treatment:

Drug: CT-P27 45 mg/kg

Placebo

Placebo Comparator group

Description:

Placebo will be administrated once in IV infusion.

Treatment:

Drug: Placebo