This study has the purpose to demonstrate prospect of benefit of EDI048 on clinical signs and symptoms of cryptosporidiosis to facilitate trial in target population, pediatric patients.
This study aims to investigate the efficacy of a new chemical entity, EDI048, in a controlled human infection model of cryptosporidiosis induced by administration of ABO809 in healthy adults, who become symptomatic with disease thereby demonstrating a prospect of benefit for use of EDI048 in children afflicted with cryptosporidiosis.
Signed informed consent must be obtained prior to participation in the study.
Ability to communicate well with the Investigator, and to understand and comply with the requirements of the study.
Male and female participants must be between 18 to 50 years of age and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening and Baseline.
Demonstrate thorough understanding of cryptosporidiosis and measures to prevent secondary spread via education provided at screening.
History of Cryptosporidium infection.
Current (based on screening laboratory tests) or history of infectious diarrhea associated with international travel in the last 12 months or C. difficile infection within 6 months prior to Screening.
Employment as a healthcare worker with direct patient care, in a daycare center (e.g., for children or the elderly), or direct food handler (individuals who work directly with food in commercial establishments).
a pregnant woman,
Parallel
Cryptosporidium parvum oocysts (ABO809)
Biological/VaccineABO809 oral suspension, single dose
EDI048
DrugEDI048 administered orally
Placebo
Other interventionPlacebo administered orally
Average stool grade after the initiation of EDI048 or placebo treatment
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
Maximum stool grade after the initiation of EDI048 or placebo treatment
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
Time to resolution of clinical diarrheal illness
To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.
Number of participants with associated gastrointestinal symptoms
To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.
Number of diarrhea episodes per participant
To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.
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