NCT02071914

Brief Summary

This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

April 8, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

February 24, 2014

Results QC Date

February 28, 2020

Last Update Submit

March 25, 2020

Conditions

Influenza A

Keywords

efficacysafety

Outcome Measures

Primary Outcomes (1)

  • Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR

    AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine

    Three times a day from Day 1(the day after virus inoculation) to Day 9

Study Arms (3)

CT-P27 10mg/kg

EXPERIMENTAL

CT-P27 will be administrated once in IV infusion.

Drug: CT-P27

CT-P27 20mg/kg

EXPERIMENTAL

CT-P27 will be administrated once in IV infusion.

Drug: CT-P27

Placebo

PLACEBO COMPARATOR

Placebo will be administrated once in IV infusion.

Drug: Placebo

Interventions

CT-P27DRUG

Influenza A treatment drug.

CT-P27 10mg/kgCT-P27 20mg/kg
PlaceboDRUG

Placebo.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male \& Female volunteers

You may not qualify if:

  • Current clinically significant disease
  • Pregnant or nursing mother
  • Abnormal pulmonary function, nose or nasopharynx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retroscreen Virology Ltd.

London, United Kingdom

Location

Limitations and Caveats

Serious Adverse Events and Other (Not Including Serious) Adverse Events are treatment-emergent adverse events.

Results Point of Contact

Title
Head of Clinical Planning Department
Organization
Celltrion
contact@celltrion.com
82328505000

Study Officials

  • SuEun Song

    Celltrion Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

February 15, 2014

Primary Completion

May 19, 2014

Study Completion

June 19, 2014

Last Updated

April 8, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-03

Locations

GB(1)