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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Cryptosporidium parvum oocysts (ABO809)
  ABO809 oral suspension, single dose
• Препарат EDI048
  EDI048 administered orally
• Другое Placebo
  Placebo administered orally

Первичные конечные точки

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

Вторичные конечные точки (12)

• Maximum stool grade after the initiation of EDI048 or placebo treatment [Срок оценки: Day 3, Day 4 and Day 5]
• Time to resolution of clinical diarrheal illness [Срок оценки: up to Day 35]
• Number of participants with associated gastrointestinal symptoms [Срок оценки: up to Day 35]
• Number of diarrhea episodes per participant [Срок оценки: up to Day 35]
• Overall diarrheal stool weight [Срок оценки: up to Day 35]
• Stool grade by stool grade category [Срок оценки: up to Day 35]
• Number of participants with fecal shedding of Cryptosporidium parvum oocysts [Срок оценки: 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 [Срок оценки: up to Day 35]
• PK parameter: Cmax [Срок оценки: up to Day 5]
• PK parameter: Tmax [Срок оценки: up to Day 5]
• PK parameter: AUC0-t [Срок оценки: up to Day 5]
• PK parameter: AUClast [Срок оценки: up to Day 5]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT07249463 · CEDI048A12201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗