Study of Efficacy and Safety of ABO809 in Healthy Participants

Novartis

Status and phase: Completed; Phase 1

Conditions: Cryptosporidium Infection, Cryptosporidiosis

Treatments: Biological: Cryptosporidium parvum oocysts (ABO809)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05036668

CABO809A02101

Details and patient eligibility

About

The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).

Full description

This study was funded by the Wellcome Trust. This Phase 1 Cryptosporidium controlled human infection model (CHIM) study employed 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 were enrolled in cohorts of approximately 10 participants who received ABO809 on the same day (Day 1). The study consisted of three sequential cohorts which were dosed one after the other for a total of 30 participants. A dose level group received the same ABO809 dose and could be comprised of multiple cohorts. The first dose level group started with a cohort of 10 participants who received ABO809 at a dose of 1x10^4 oocysts. The study continued to enroll participants in the same dose level group if the desired incidences of infection and diarrheal illness were observed, up to a total of approximately 30 participants. If the desired incidences of infection and diarrheal illness were not observed, a new dose level group, receiving ABO809 at a dose of 1x10^6 oocysts, could be initiated. If needed to optimize the model, intermediate ABO809 doses could be evaluated.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
• Good health
• Ability to communicate well with the Investigator

Exclusion criteria

• History of Cryptosporidium infection, gastrointestinal conditions (including diarrheal syndromes, gastroenteritis and gastrointestinal tract surgery), immunodeficiency, infections, significant medical concerns, hypersensitivity to nitazoxanide or other specified antibiotics.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ABO809

Experimental group

Description:

Participants will receive ABO809 at a single oral dose of 1x10\^4 oocysts. Other doses such as 1x10\^6 oocysts may be considered to optimize the model

Treatment:

Biological: Cryptosporidium parvum oocysts (ABO809)