The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to
determine if antibodies that protect against anthrax are formed after treatment with
NasoShield, and to determine whether the formation of these antibodies are affected by
different positions of administration.
Description
After being informed about the study and potential risks, all healthy volunteers that have
given written informed consent will undergo screening to determine eligibility for study
entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1
of 3 treatment groups. Within the treatment group, the participant will be randomized in a
double-blind manner in a 5:2 ratio to NasoShield or placebo.
The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29
after qualifying into the study. The position of administration and the amount of time the
subject will need to stay in the specified position will depend on the group to which the
subject is assigned.
Participants will return to the investigational site for multiple visits through Day 210
(approximately 6 months after the second dose). At each visit, the participant will be asked
about interim medical history and use of any medications, and safety and immunogenicity
assessments will be performed.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
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