Study of Efficacy and Safety of ABO809 in Healthy Participants

NCT05036668 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CABO809A02101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Cryptosporidium Infection, Cryptosporidiosis

Keywords

Controlled Human Infection Model, safety, tolerability, healthy volunteers, cryptosporidiosis, ABO809

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration

  Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding.

  At ≥72 hours post-administration (or sooner if associated with symptoms suggestive of diarrheal illness) up to Day 10 (inclusive).

Secondary Outcomes (12)

• Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration

  From Day 1 up to Day 28

• Number of Diarrhea Stools Per Participant

  From Day 1 up to Day 28

• Overall Diarrheal Stool Weight

  From Day 1 up to Day 28

• Maximum Stool Grade by Stool Grade Category

  From Day 1 up to Day 28

• Time to Onset of Clinical Diarrheal Illness

  From Day 1 up to Day 28

Study Arms (1)

ABO809

EXPERIMENTAL

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

Biological: Cryptosporidium parvum oocysts (ABO809)

Interventions

Cryptosporidium parvum oocysts (ABO809) BIOLOGICAL

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

ABO809

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cryptosporidiosis

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Study Officials

• Mohamed Al-Ibrahim

  Pharmaron CPC, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cryptosporidium controlled human infection model

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 5, 2021
• Study Start: April 7, 2022
• Primary Completion: November 7, 2022
• Study Completion: December 27, 2022
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)