Cryptosporidium Infection, Cryptosporidiosis Clinical Trial
An Open Label Cryptosporidium Controlled Human Infection Model (CHIM) to Assess the Efficacy and Safety of ABO809 in Healthy Participants
The purpose of this Phase I controlled human infection model (CHIM) study is to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers results in a Cryptosporidium infection and diarrheal illness. The study will measure fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).
This study is funded by the Wellcome Trust. This Phase 1 Cryptosporidium controlled human infection model (CHIM) study employs a single-center, open-label design to characterize the incidence of infection and associated symptoms following the administration of single doses of Cryptosporidium parvum oocysts (CE). Healthy volunteers will be enrolled in cohorts of approximately 10 participants who will receive ABO809 on the same day (Day 1). The study will consist of three (to a maximum of six) sequential cohorts which will be dosed one after the other for a total of 30 (to a maximum of approximately 60) participants. A dose level group will receive the same ABO809 dose and can be comprised of multiple cohorts. The first dose level group will start with a cohort of 10 participants who will receive ABO809 at a dose of 1x10^4 oocysts. The study will continue to enroll participants in the same dose level group if the desired incidences of infection and diarrheal illness are observed, up to a total of approximately 30 participants. If the desired incidences of infection and diarrheal illness are not observed, a new dose level group, receiving ABO809 at a dose of 1x10^6 oocysts, may be initiated. If needed to optimize the model, intermediate ABO809 doses may be evaluated. ;