MedTrace Logo

Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model

NCT02371668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-03-17

Study results available
· View outcomes & findings →

Summary

Background:

\- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms.

Objective:

\- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo.

Eligibility:

\- Healthy nonsmokers ages 18 45.

Design:

* Participants will be screened under a separate protocol.
* Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up.
* Participants will stay in a hospital isolation unit for at least 10 days.
* They will have:
* Medical history
* Physical exam
* Blood and urine tests
* Heart and lung test
* Tests for drugs and alcohol
* Throughout their stay, participants will:
* Be closely watched by a medical team
* Have nasal washes and swabs several times a day
* Participants will have the flu virus sprayed in each nostril.
* The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get.
* Participants can go home after 10 days if they test negative for the flu 2 days in a row.
* Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.

Conditions

  • H1N1 Influenza Healthy Volunteers

Interventions

BIOLOGICAL

CR6261

50 mg/kg administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).

BIOLOGICAL

Placebo

Administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02371668 on ClinicalTrials.gov