ReclutandoNCT07249463Registro de ClinicalTrials.gov

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

Cryptosporidiosis

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 50 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 80 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento doble

EDI048

Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally.

Biological: Cryptosporidium parvum oocysts (ABO809) · Drug: EDI048

Placebo

Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally.

Biological: Cryptosporidium parvum oocysts (ABO809) · Other: Placebo

Cryptosporidium parvum oocysts (ABO809) BIOLOGICAL

ABO809 oral suspension, single dose

EDI048 DRUG

EDI048 administered orally

Placebo OTHER

Placebo administered orally

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Average stool grade after the initiation of EDI048 or placebo treatment

Plazo: Day 3, Day 4 and Day 5

To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.

Medidas secundarias

Maximum stool grade after the initiation of EDI048 or placebo treatment

Plazo: Day 3, Day 4 and Day 5

To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.

Time to resolution of clinical diarrheal illness

Plazo: up to Day 35

To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.

Number of participants with associated gastrointestinal symptoms

Plazo: up to Day 35

To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.

Number of diarrhea episodes per participant

Plazo: up to Day 35

To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.

Overall diarrheal stool weight

Plazo: up to Day 35

To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.

Stool grade by stool grade category

Plazo: up to Day 35

To evaluate the efficacy of EDI048 vs. placebo based on signs and symptoms associated with clinical diarrheal characteristics.

Number of participants with fecal shedding of Cryptosporidium parvum oocysts

Plazo: up to Day 35

To evaluate the incidence of and time to resolution of Cryptosporidium infection in participants who received EDI048 vs. placebo.

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

Plazo: up to Day 35

To quantify fecal shedding of oocysts in participants who received EDI048 vs. placebo and to assess time to resolution of infection.

PK parameter: Cmax

Plazo: up to Day 5