Actively Recruiting
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
Led by Novartis Pharmaceuticals · Updated on 2026-04-27
96
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participation
- Ability to communicate and comply with study requirements
- Male and female adults aged 18 to 50 years in good health based on medical history, physical exam, vital signs, ECG, and lab tests
- Understanding of cryptosporidiosis and prevention measures after education
- Body mass index (BMI) between 18 and 32 kg/m2
- No prior participation with ABO809 or EDI048 in clinical trials
You will not qualify if you...
- History of Cryptosporidium infection
- Current or past infectious diarrhea related to international travel in last 12 months or C. difficile infection within 6 months
- Employment in healthcare with direct patient care, daycare centers, or as direct food handlers
- Living with a pregnant woman, child under 4 years, adult over 65 years, infirmed, or immunocompromised person
- Residence in dormitories with shared bathrooms
- Significant medical history including cardiac, pulmonary, gastrointestinal, renal, endocrine, reproductive, immune, or other system conditions
- Use of investigational drugs within 5 half-lives or 30 days prior to enrollment
- Women who are pregnant, nursing, or of child-bearing potential not using effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Pharmaron Inc
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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