Study of Efficacy and Safety of ABO809 in Healthy Participants

NCT ID: NCT05036668

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2022-12-27

Brief Summary

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).

Detailed 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.

Conditions

Cryptosporidium Infection, Cryptosporidiosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ABO809

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

Group Type: EXPERIMENTAL

Cryptosporidium parvum oocysts (ABO809)

Intervention Type: BIOLOGICAL

ABO809 3x10\^6 CE/3mL concentrate for oral suspension, single dose at Day 1

Interventions

Cryptosporidium parvum oocysts (ABO809)

ABO809 3x10\^6 CE/3mL concentrate for oral suspension, single dose at Day 1

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Al-Ibrahim

Role: PRINCIPAL_INVESTIGATOR

Pharmaron CPC, Inc.

Locations

Novartis Investigative Site

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CABO809A02101

Identifier Type: -

Identifier Source: org_study_id