MedTrace Logo

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

NCT03511066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2022-10-31

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

CT-P27 90 mg/kg

Influenza A treatment drug.

DRUG

CT-P27 45 mg/kg

Influenza A treatment drug.

DRUG

Placebo

Placebo.

Sponsors & Collaborators

Principal Investigators

  • MoonSun Choi · Celltrion Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2018-03-09
Completion
2018-06-15
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511066 on ClinicalTrials.gov