Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults

Official title

A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Assess the Efficacy and Safety and Tolerability of EDI048 in a Cryptosporidium Controlled Human Infection Model (CHIM) in Healthy Participants

Overview

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.

Detailed description

This study is a Placebo-controlled, participant- and investigator-blinded multicenter trial in healthy adult volunteers who are administered Cryptosporidium parvum oocysts (ABO809) to develop diarrhea and symptoms consistent with cryptosporidiosis. After developing diarrhea, participants will be randomized 1:1 to treatment with EDI048 or placebo in parallel.

Interventions

• Biological Cryptosporidium parvum oocysts (ABO809)
  ABO809 oral suspension, single dose
• Drug EDI048
  EDI048 administered orally
• Other Placebo
  Placebo administered orally

Primary outcome measures

• Average stool grade after the initiation of EDI048 or placebo treatment [Time frame: Day 3, Day 4 and Day 5]

Secondary outcome measures (12)

• Maximum stool grade after the initiation of EDI048 or placebo treatment [Time frame: Day 3, Day 4 and Day 5]
• Time to resolution of clinical diarrheal illness [Time frame: up to Day 35]
• Number of participants with associated gastrointestinal symptoms [Time frame: up to Day 35]
• Number of diarrhea episodes per participant [Time frame: up to Day 35]
• Overall diarrheal stool weight [Time frame: up to Day 35]
• Stool grade by stool grade category [Time frame: up to Day 35]
• Number of participants with fecal shedding of Cryptosporidium parvum oocysts [Time frame: up to Day 35]
• Number of oocysts per gram per day (wet and dry weight) and the total number of oocyst per day measured by qPCR in fecal samples [Time frame: up to Day 35]
• PK parameter: Cmax [Time frame: up to Day 5]
• PK parameter: Tmax [Time frame: up to Day 5]
• PK parameter: AUC0-t [Time frame: up to Day 5]
• PK parameter: AUClast [Time frame: up to Day 5]

Eligibility criteria

Inclusion criteria

• 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.
• Must have a body mass index (BMI) within the range of 18-32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
• Have not received ABO809 or EDI048 in prior clinical trials.

Exclusion criteria

• 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).
• Participants who share a home with any of the following:
• a pregnant woman,
• a person <4 years old or >65 years old,
• a person who is infirmed,
• a person who is immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).
• Residents of dormitories with shared bathrooms would also be excluded.
• Any significant medical history including, but not limited to, conditions of the cardiac, pulmonary, gastrointestinal, renal, endocrine, reproductive, immune or other systems.
• Use of investigational drugs within 5 half-lives of the drug or its major metabolites or 30 days of enrollment (Day 1), whichever is longer.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the trial; pregnant or nursing (lactating) women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Pharmaron Inc — Baltimore
• Cinn Children Hosp Medical Center — Cincinnati

Identifiers

NCT: NCT07249463 · CEDI048A12201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗