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

Completed · Phase 2 · Has a placebo group

Conditions studied: H1N1 Influenza Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02371668

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

104

Starts

2015-02-25

Expected to finish

2018-11-30

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae.
• Hyperlipidemia requiring medical therapy per current American College of Cardiology (ACC) and American Heart Association (AHA) guidelines published in 2013.
• Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• Persons greater than or equal to 65 years of age.
• Children less than or equal to 5 years of age.
• Residents of nursing homes.
• Persons of any age with significant chronic medical conditions such as:
• Chronic pulmonary disease (e.g., severe asthma, COPD).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., insulin dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or cancer.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Individuals who are receiving long-term aspirin therapy.
• Women who are pregnant or who are trying to become pregnant.
• Positive serology for hepatitis C virus antibody or hepatitis B surface antigen.
• Individual with body mass index (BMI) greater than or equal to 18 and greater than or equal to 35 or weight > 114kg.
• Acute illness within 7 days of admission and inoculation with the challenge virus (Day -1).
• Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (DLM) normal reference range and deemed clinically significant by the PI.
• Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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