ReclutandoNCT07235059Registro de ClinicalTrials.gov

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease

Chronic Kidney Disease

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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 1
Rango de edad: 18 años - 65 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 112 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

The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.

Leer la descripción completa

This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.

¿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:

Able to provide written informed consent before any assessment is performed.

Part A (HV):

• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.

Parts B \& C (CKD)

• Male and female participants 18 to 65 years of age.

Exclusion Criteria:

Women of childbearing potential.
Sexually active males unwilling to use contraception.

Part A (HV):

Clinically significant abnormal blood pressure, defined as SBP \<90 mmHg or \>140 mmHg or DBP \<55 mmHg or \>95 mmHg.
Abnormal resting HR, defined as \<45 bpm or \>90 bpm.

Part B \& C (CKD)

History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.
Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.
History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).

Other protocol defined inclusion/exclusion criteria may apply.

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

Part A: OJR520 dose A1

Participants will receive OJR520 dose level A1.

Drug: OJR520

Part A: OJR520 dose A2

Participants will receive OJR520 dose level A2.

Drug: OJR520

Part A: OJR520 dose A3

Participants will receive OJR520 dose level A3.

Drug: OJR520

Part A: OJR520 dose A4

Participants will receive OJR520 dose level A4.

Drug: OJR520

Part A: OJR520 dose A5

Participants will receive OJR520 dose level A5.

Drug: OJR520

Part A: OJR520 dose A6

Participants will receive OJR520 dose level A6.

Drug: OJR520

Part B: OJR520 dose B1

Participants will receive OJR520 dose level B1.

Drug: OJR520

Part B: OJR520 dose B2

Participants will receive OJR520 dose level B2.

Drug: OJR520

Part B: OJR520 dose B3

Participants will receive OJR520 dose level B3.

Drug: OJR520

Part B: OJR520 dose B4

Participants will receive OJR520 dose level B4.

Drug: OJR520

Part C: OJR520 dose C1

Participants will receive OJR520 dose level C1.

Drug: OJR520

Part C: OJR520 dose C2

Participants will receive OJR520 dose level C2.

Drug: OJR520

Part C: OJR520 dose C3

Participants will receive OJR520 dose level C3.

Drug: OJR520

Part C: OJR520 dose C4

Participants will receive OJR520 dose level C4.

Drug: OJR520

Part A: Placebo

Participants will receive the matching placebo.

Other: Placebo

Part B: Placebo

Participants will receive the matching placebo.

Other: Placebo

Part C: Placebo

Participants will receive the matching placebo.

Other: Placebo

OJR520 DRUG

Participants will receive OJR520 in different dose levels.

Placebo OTHER

Participants will receive OJR520 matching placebo.

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

Plazo: From Day 1 (Part A) until Day 71 (Part C)

Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.