WASHINGTON (dpa-AFX) - The National Institutes of Health announced the commencement of phase 1 clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 or EV-D68, which can cause severe respiratory and neurological diseases such as acute flaccid myelitis or AFM.
NIH said, 'According to the CDC, EV-D68 was first identified in California in 1962 and is one of more than 100 non-polio enteroviruses. EV-D68 typically causes respiratory illnesses that are mild. Non-polio enteroviruses are very common. Most infections are asymptomatic or cause mostly mild symptoms, such as runny nose, sneezing, cough, rash, mouth sores, body aches, and muscle aches. Severe symptoms may include wheezing and difficulty breathing'.
Currently, there are no U.S. Food and Drug Administration-approved drugs to treat AFM, which likely spreads from person to person when an infected person coughs, sneezes, or touches a surface that is then touched by others.
Sponsored by NIH's National Institute of Allergy and Infectious Diseases, the trial will focus on evaluating EV68-228-N's safety, longevity in the body, and the most effective dosage.
EV68-228-N was developed by scientists of Vanderbilt University Medical Center, Nashville, Tennessee, in collaboration with Utah State University, KBio, Inc., and ZabBio.
The trial involves 36 healthy individuals aged 18 to 49, of which six participants will receive placebo, whereas 30 will receive varying doses of EV68-228-N.
NIH said that scientists will monitor the first two study participants in each group receiving the experimental treatment for at least 72 hours before administering it to others to ensure safety.
Following this, researchers will perform nine subsequent in-person examinations over the next 120 days.
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