Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model
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.
Timeline
- Start
- 2015-02-25
- Primary completion
- 2018-11-30
- Completion
- 2018-11-30
Outcome
Missed primary endpoint
registry analysis (superiority test); CR6261 vs Placebo Comparator; p = 0.31; Wilcoxon (Mann-Whitney) NCT02371668 ↗
paper CR6261 had no statistically significant effect on AUC PMID 33211860 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DIRIDAVUMAB | Monoclonal antibody | 50 mg/kg | Intravenous |
Indications
No indication recorded.